services for development and quality assurance medical ... · we make medical devices safe and...

EXCO. The Quality CompanySolutions for Industry and R&DEXCO. The Quality CompanySolutions for Industry and R&D

Services for Development and Quality Assurance

Medical Technology

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Vorwort

Überblick Leistungsportfolio Unsere Kernkompetenzen

Projektunterstützung im medizintechnischen Umfeld

Projektreferenzen: Entwicklung eines Blutzuckermessgeräts einschließlich Produktions- und Prüfplatzentwicklung

• Entwicklung der Embedded Software für ein modifiziertes Blutzuckermessgerät

• Verifizierung der Embedded Software für ein modifiziertes Blutzuckermessgerät

• Geräte-Evaluation für ein neues Blutzuckermessgerät

• Entwicklung und Inbetriebnahme von Prüfplätzen für eine Blutzuckermessgeräteproduktion

• Qualifizierung von Prüfplätzen und Validierung der Produktionslinie

• Durchführung einer Konformitätsbewertung und Erstellung einer EU-Konformitätserklärung

Methoden-Entwicklung für die Labordiagnostik

Transfer einer Produktionsanlage für Medizingeräte

Entwicklung von alternativen Dosierkonzepten für die Reagenzien-Applikation

Gap-Analyse für bestehende Produktakten

Execution of a mock FDA auditschen FDA-Audits

Sicherheitsprüfung von IVD-, Labor- oder Medizingeräten

Schulungsangebot Zahlen und Fakten, Ansprechpartner

Inhalt

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Preamble

Services overview Our core competencies

Project support in the medical technology environment

Project references: Development of a blood glucose meter including production- and test stand development

• Development of the embedded software for a modified blood glucose meter

• Verification of the embedded software for a modified blood glucose meter

• Device evaluation for a new blood glucose meter

• Development and commissioning of test stands used in the production of blood glucose meters

• Qualification of test stands and validation of the production line

• Conformity assessment and issuing an EU declaration of conformity

Method development for laboratory diagnostics

Transfer of production equipment for medical devices

Development of alternative dosing concepts for dispensing IVD reagents

Gap analysis for device master files

Completion of a mock FDA audit

Safety test for IVD, laboratory or medical devices

Trainings Facts and figures, contacts

Contents

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Services from one single source

Time pressure in projects, shortened development cy-cles and the wish to be able to dedicate oneself wholly to one’s core tasks are today’s challenges. It is therefore desirable to have a reliable DIN EN ISO 13485 certi-fied partner by your side. A partner who provides you with professional and flexible advice with all of your ques-tions surrounding the imple-mentation of quality goals in medical devices; a partner who actively relieves you of your workload.

We, the EXCO company and our employees, see ourselves as such a partner. For many years, we have been working on behalf of our developing and manufacturing clients in the field of medical technology.

We develop and verify software, particularly software for embedded systems. We validate systems and qualify processes and facilities. We are specialists in the field of product test-ing, laboratory analytics, method validation as well as the development and validation of

production and testing sys-tems. Our expertise spans the three regulatory classes for active and passive medi-cal devices. You can rely on our employees at all times. Whether you need help with the development of your suppliers, preparing for regulatory inspections or the preparation and creation of product documentation for submission.

In addition to this, our firm is also an accredited training provider of workshops and sem-

inars surrounding medical technology topics.

Market-leading companies in the field of med-ical technology trust in our expertise. For this reason, they choose to rely on our services again and again and recommend them. This, for us, is the greatest of compliments.

Convince yourself of our quality. On the fol-lowing pages, you will find detailed descrip-tions of the EXCO services and detailed project references.

Best regards,

Andreas Horchler Head of Sales, EXCO GmbH

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PRODUCTION SYSTEMS AND TEST STANDS

SOFTWARE AND SYSTEMS DEVELOPMENT

We make medical devices safe and reliable for diagnoses

and therapyInnovation is the lifeblood of the medical technology market. Sophisticated medical devices with embedded systems help to diag-nose illnesses and to provide treatments.

EXCO supports international companies with technical services. Thus, technological chal-lenges can be mastered and the safety of prod-ucts and applications can be ensured.

CONSULTING

LABORATORY ANALYSISQUALITY

ASSURANCE

Software development

Embedded development

Design

Project management

Risk management

Analysis

Creation of technical documentation

Concept development Assay development

Methods validation

Laboratory transfer

Systems Transfer

Automation

Qualification

Measuring technology

Product packaging

Evaluation

Mock audits

Verification Development of QA systems

Gap analysis

Validation

Supplier assessment

Supplier development

TRAINING

Product safety

Architecture

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Our core competencies

EXCO brings together a wide range of core areas of expertise under one roof so that you receive comprehensive solutions from one single source. Our employees are able to provide you with professional advice concerning all of our areas of expertise. They can realize your projects on a results-oriented and reliable basis.

EXCO develops effective chemical analytical methods for the characterization and assessment of ingredients/raw materials as regards their purity and reactivity.

We carry out laboratory analysis. In addition to this, we also optimize and validate your methods in strict conformity with the guidelines from the medical technology and pharmaceutical environment.

EXCO carries out supplier audits and prepares you for regulatory inspections.

We assess your suppliers and their processes to ensure conformity with your quality requirements. We are able to prepare you for regulatory in-spections by providing mock audits similar to the activities and contents of the official audit.

EXCO provides automation solutions for the production environ-ment. We automate sensitive production and testing processes. With the key focus on process control engineering and control technology, we can offer individual and manufacturer-independent solutions for process automation. From the concept to the realization, to the qualification – everything from one single source.

EXCO creates technical documentation compliant to standards so that you are able to provide solid proof that defined require-ments for products, processes or systems are fulfilled on a repro-ducible basis.

Our employees have been trained to diligently document all of their tasks in accordance with their working environment and the regula-tory requirements. We document all of the required method based artefacts using specialist tools. Thus, we ensure optimum traceability.

Analyzing

Auditing

Automating

Documenting & reviewing

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Developing

Measuring & testing

Validating and qualifying

Verifying

Visualizing

EXCO develops software and system solutions for production and testing systems, embedded systems, information management and for apps.

We also develop measuring processes for the smallest of electrical currents and voltages. As well, we develop enzyme chemistry for your tests. Furthermore, we develop your suppliers‘ processes with regard to conformity with both your and the regulatory quality requirements.

EXCO develops production and testing systems for devices and components, for small batches all the way through to mass production.

Our expertise is in electrical, mechanical and optical testing. We focus on developing of individual test stands as well as on integrating them in testing and production lines.

EXCO is a reliable partner for the GMP-compliant validation of your production and supplier processes as well as for the qualifi-cation of your equipment and IT systems.

We provide documented proof that a process, a procedure, a method or a document reproducibly satisfies the previously specified requirements in the field and is therefore suitable for the specific task.

EXCO is able to manage your verification projects and to put your products to the comprehensive test.

We realize all of your verification activities. In this context, we test your devices for their environmental compatibility and verify the firmware in your embedded systems. According to the specific situation, we complete automated or manual tests. As regards automated tests, our goal is to carry out a wide range of fully automatic tests as quickly as possible at the touch of a button. For the purpose of verification, along with other approaches, we use white-box tests and black-box tests.

EXCO brings critical situations onto your screen.

We visualize complex process contexts and make the operational testing logic visible on visualization panels. Human-machine interfaces and SCADA systems help to visualize sophisticated processes for monitoring, control, and data capture in the process control technology, also with links to databases and higher-level systems.

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EXCO is pleased to be your reliable partner in all domains along the long journey from the initial product idea to the approval, to the downstream product care. We can offer customized support with the development of products, as well as for production and test-

ing systems, and also for the development of the chemical laboratory analytics. As proven experts in the regulatory environment (FDA, GxP, IEC), we can support you throughout the Life Cycle Management.

Project support in the medical technology environment

Auditing Quality management

Documenting & reviewing Risk management

Developing

Information systems

Developing Suppliers

Documenting & reviewing CAPA and change managementInfrastructure


Auditing


Validating

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Product

Developing

Verifying

Measuring & testing


Developing Measuring methods Device

Software

Verifying Mechanics

Electronics

Production

Developing

Developing

Measuring & testing

Disposable Production

Analytics

Approval

Measuring & testing

Approval

Chemistry/reagent

Verifying

Verifying

Automating

Developing

Validating & qualifying

Visualizing

Analyzing

Verifying

Automating


Visualizing

Analyzing



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Development of a blood glucose meter including production- and test stand development

Client benefits

Reference project

« Clients value us as being a reliable, flexible and innovative partner. With our wide ranging portfolio and our expertise we make use of synergies

which enable their products to go onto the market at an earlier stage. »Andreas Horchler,

Head of Sales, EXCO GmbH

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A client would like to modify a blood glucose meter. The hardware of the measuring device has previously been revised and completely restructured.

The client assigns EXCO with the

• Developmentoftheembeddedsoftware for a modified blood glucose meter

• Verificationoftheembeddedsoftware for a modified blood glucose meter • Devicesassessmentforanewbloodglucosemeter

• Developmentandcommissioningofteststands used in the production of blood glucose meters

• Qualificationofteststands and validation of the production line

• Conformityassessmentandissuing an EU declaration of conformity

Since the client benefits from receiving several services from one single source, coordination activities between the client and EXCO are reduced. This shortens development times and thereby reduces costs.


Developing

Measuring & testing


Verifying

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Development of the embedded software for a modified blood glucose meter

Reference project: Development of a blood glucose meter . . .

A client assigns EXCO with the embedded software development for a modified blood glucose meter: The existing software has to be adapted to the new hardware (1 processor instead of 2 processors), and new client requirements have to be implemented.

• Forthenecessarychanges,EXCOcreatesrequirementspecifications and draft designs to be implemented after approval.• Throughtherestructuringofthecommunicationdriverconcept, EXCO achieves a higher performing level of communication. Detailed solutions include: • software adaptation of device-side USB-drivers, • software adaptation of external software modules (PHDC stack), • integration of existing modules for control software and optimization. • EmbeddedCwithIARWorkbench• Microkernel(certifiedforclassIIImedicaldevices)• ArmCortexprocessor

• Customized and precise system solutions• High performance communication

Manufacturer of medical devices and diagnostic equipment, Germany

Activities

Implementation

Technologies used

Client

« The developed modules can be put to a wide range of subsequent uses. This results in shorter development times. »

Dr. Andreas Kreuzer, Project Manager Embedded & Mobile Apps, EXCO GmbH

Client benefits

Developing

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The client assigns EXCO with the test design and test completion as well as the test management for the verification of the embedded software in a blood glucose meter.

•Testdesignandcompletionoftest •Creation of test specifications for automated and manual tests •Creation of test drivers and stubs for automated tests •Development and operation of test environments for automated tests •Completion of tests to accompany the development •Completion of formal verification tests and black-box tests •White-box tests, code reviews, static code analysis •Implementation and presentation of reviews •Creation of test documentation •Creation of error reports

• Testmanagement • Professional project management of software verification projects • Planning and steering of tests • Creation and leadership of test teams •Selection of test media and tools •Specification and monitoring of test documentation •Creation of final reports •Budget planning and monitoring •Deviation management

•HPQualityCentre•Microsoft®VisualStudio•NUnitTestframework

Reduction of costs during verification loops because of automated tests.


Verification of the embedded software for a modified blood glucose meter

Client benefits


Implementation

Activities

Client

Verifying

Technologies used

« We do not accept any tolerance during verification. »Werner Kunzmann,

Head of Unit Hardware Evaluation, EXCO GmbH

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Documenting & Reviewing

Measuring & testing


Verifying

A client wants to prove the environmental compatibility of a blood glucose meter and wants to ensure that all product requirements are met.

EXCO is assigned with the completion of electrical and mechanical tests for the conformity evaluation as regards the device safety. EXCO executes type tests for the conformity evaluation on components, devices and device systems:

•ElectricalmedicaldevicesaccordingtoDINENIEC60601-1•Equipmentformeasurement,controlandlaboratoryuseaccording toDINENIEC61010-1•ElectricaloutfittingofmachinesaccordingtoDINENIEC60204-1•IVDproductsaccordingtoDINENIEC61010-2-101•MEdevicesystemsaccordingtoDINENIEC60601-1-1•Informationtechnologyinstallationsaccordingto DINENIEC60950-1•UsabilityaccordingtoDINENIEC60601-1-6•Evaluationanddatalogging

•Walk-inclimatechamberinwhichdevicesaretestedunderactual conditions (temperature, air humidity)•Generatorforelectrostaticenergywhichistransferredtothetest sample•EMCtestchambers(equipmentwasprovidedbythecustomer)

Safe products through functional tests:• Electromagnetic compatibility (EMC)• Electrostatic discharge (ESD)• Thermal loads• Mechanical loads• Environmental loads


Device evaluation for a new blood glucose meter


Implementation

Activities

Client

« We do not accept any tolerance during verification. »Werner Kunzmann,

Head of Unit Hardware Evaluation, EXCO GmbH

Client benefits

Technologies used

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Developing

Measuring & testing

« The synergies were put to optimum use, as we completed both the development and the validation. »

Tobias Matheis, Head of Unit Test Stand Development, EXCO GmbH

Development and commissioning of test stands used in the production of blood glucose meters


A client assigns EXCO with the development and commissioning of test stands: Significant collaboration for creating a testing concept for a semi-automatic production line with an annual output in the six-figure range. Further development of the test stands parallel to the development of the equipment, starting with the testing of the functional models through to series production.

A test stand framework developed in-house by EXCO is used. This contains a wide range of standard tasks such as the recording of the measuring signal, the activation of the periphery, linking with the database and the simulation of the hardware; only the project-specific testing steps require implementation.

Programming language C++ and C#

• Cost reduction and shorter development times due to the use of a framework developed by EXCO in-house which already fulfils a wide range of standard tasks.• Development and validation services from one single source lead to a reduced coordination workload for the client.


Activities

Implementation

Technologies used

Client

Client benefits

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Qualification of test stands and validation of the production line


Implementation

Activities


Technologies used

« Due to the close collaboration with the development department we were able to optimize the test interfaces and therefore hugely increase

the efficiency during the verification phase. »Daniel Brendel,

HeadofUnitProcessQualification,EXCOGmbH

Client benefits

A client assigns EXCO with the qualification of the test stands and the validation of the production line for a blood glucose meter.

The building of automated software tests takes place immediately after the specification of a test step. To be able to complete this during the development and independently of the hardware, these tests are simulated using software.

•TeststandframeworkdevelopedbyEXCOwithsimulatedtestlinks•ProgramminglanguageC++,C#

• Cost reduction due to synergy effects between development and validation.• Earlier availability of the production line through development- accompanying, documented tests which are used for the qualification.

Medical technology manufacturer, Ireland/ChinaClient

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« EXCO combines development expertise with know-how in the area of product safety, qualification and validation. »

Stephan Blab,HeadofCompetenceCenterProcessQualification,EXCOGmbH

Conformity assessment and issuing an EU declaration of conformity


EXCO is assigned with the testing of production safety and preparing an EU declaration of conformity.

•Qualification(IQ,OQ,SAT,FAT,validationreport,riskanalysis)•Verifyingofproductsafety • Operation instructions in English compliant to DINENISO82079-1 • Risk assessment according to machinery directive 2006/42/EC • Risk Evaluation • Inspection of safety precautions • Researching regulations and standards • Compilation of technical documentation • Specification of compliance (RoHS, MRL, NSP, EMC) for supplier parts • Review of the technical documentation • Issuing of an EU declaration of conformity

• Services from one single source from concept to qualification.• Efficient risk management by specialists.

Medical technology manufacturer, Ireland

Activities and implementation

Client

Client benefits

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Analyzing

Developing


« We offer the highest quality and a reliable service to the manufacturers of diagnostic devices – so that diseases can be

diagnozed at an early stage and treated correctly. » Tatjana Burchart,

HeadofUnitLaboratoryAnalysis-MethodValidation,EXCOGmbH

Method development for laboratory diagnostics

Reference project

A client wants to develop a new diagnosis procedure using biological markers. Biomarkers in point-of-care devices using standardized reaction sequences are verified with a specific method.

The client assigns EXCO for collaboration in the development of test strips and the biochemical measuring procedures.

•Developmentofbiochemicalmeasuringprocedures,particularly regarding the sensitization and minimization of interferences: proactively based on literary research and further development of standards.•Immunoassaydevelopmentforuseinpatient-sidelaboratory diagnostics. Configuration of the assay for the detection of the antigen.•Assessmentofinputmaterialsregardingpurity,impurities,enzyme activity and completion of the requested analytical measurements according to the specified work instructions and documentation of the results.•Developmentandconfigurationofateststripinthesample production.•Completionoffunctionaltestswithassembledteststrips.

• The client receives reliable information about the suitability of the newly developed measuring processes.• Shorter development times.


Activities

Client

Client benefits

Project

Implementation

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« In future, regulatory requirements will increase. As a partner in providing technical services, EXCO frees up clients’ time,

so that companies can focus on their core tasks. »Alfred Hein,

Project Manager Automation, EXCO GmbH

Transfer of production equipment for medical devices

Reference project

A client wants to transfer the production of blood gas measuring devi-ces from an EU country to Switzerland, increasing capacity at the same time. In this context, the country-specific legal and approval standards need to be taken into account.

EXCO is asked to redefine the operator requirements for the system and take responsibility for the technical planning and documentation. This is followed by purchasing new production equipment, the transfer of part of the existing system to a new location and the qualification of the system.

The client assigns EXCO with the:•technicalcoordinationofthesuppliers,•creationoftheoperatorrequirements’specifications,•creationofthefunctionalspecifications,•presentationandcompletionoftheriskanalysisandtheFMEA,•systemsqualification(IQ,OQ,FAT,SAT).

Following the inventory analysis, the operator requirements for the system are redefined in workshops with the operators and in consideration of the country-specific legal and approval standards. The technical planning and documentation is created. The risk assessmentidentifiesapproximately100majorrisks.ThetwostageFMEAanalysisincludesapprox.2,000elements.

• Relieving the clients‘ workload through EXCO‘s expertise in country-specific legal and approval standards.• Relieving the clients‘ workload by taking on the coordination work with the participating suppliers.• Reduction of costs through system transfer and qualification from one single source.

Medical technology manufacturer, Switzerland/Austria

Activities

Implementation

Client

Client benefits

Project

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Analyzing


« Working together, we developed optimum system concepts. This resulted in more flexibility and shorter development times. »

Tatjana Burchart, HeadofUnitLaboratoryAnalysis-MethodValidation,EXCOGmbH

Development of alternative dosing concepts for dispensing IVD reagents

Reference project

An association of academic and industrial partners is developing an intelligent reagent cartridge: With alternative dosing concepts for theapplicationofthereagentsinin-vitro-diagnostic(IVD)analysissystems, the consumption of reagents should be minimized per determination.ThecomplexityandspacerequirementsofIVDlaboratory systems are reduced.

An inter-divisional team is to develop an „intelligent“ reagent cartridge which completes a sensor-controlled dosing process (0.25–50μl/dosage)andthereforeenablestherealizationofanew overall system concept.

EXCO and a team of academic and industrial partners develop a reagent cartridge with an integrated dispensing unit and linear valve control. The procedure developed in collaboration with the cooperation partners is patented.

• Increasing the innovation potential.• Client gets a registered patent.


Acitivities

Client

Project

Implementation

Client benefits

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Gap analysis for device master filesReference project

DuringaTÜV(GermanTechnicalInspectionAgency)audititwasfound that the documentation of existing product lines requires checking and adaptation to the current regulatory standards to be able to continue offering the products on the market.

EXCO reviews the complete documentation of the product lines currently on the market and highlights the discrepancies as regards the currently valid regulations:

•Classificationofthedocumentationaccordingtotherequirements of the regulatory standards•Creationofananalysiswhichhighlightsthegapsthatrequire resolving•Creationofalistofmeasurestobetakenfortheclosingofthegaps•Updatingtheriskanalysis•Creationofarequirementslistfortechnicaldocumentation, including the current regulatory standards•Collaboratingonclosingthegaps

EXCO creates a dossier with lists of performance characteristics for the medical device. To prove the performance, EXCO researches study documents in the relevant product technical documentation and client archives. EXCO also compares the study reports and results with the current regulatory requirements (e.g. DIN EN ISO 18113, CLSI) and the current client standard. EXCO then assesses whether the completed studies satisfy the current regulatory standards, identifies the discrepancies, and ensures the closing of the gaps.

• The client gains an overview of the gaps in the technical documentation.• An action plan can be implemented in order to close these gaps so that the product satisfies the current requirements as specified by the authorities once again.• The subsequent TÜV audit was passed.

Medical equipment manufacturer, Germany

Activities

Client benefits

Project

Client

Implementation


Auditing

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Auditing Completion of a mock FDA auditReference project

A client wants to prepare for a pending FDA audit.

EXCOisaskedtoinspecttheQMsystemasregardsitsconformitywiththerequirementsofFDA21CFRPart820andtohighlightpossiblegapsinthedocumentationandimplementationoftheQMsystem,especially those in connection with the products that are approved in the USA.

EXCOcreatesadetailedauditplanbasedonFDA21CFRPart820requirements and completes a mock audit. In this context, the process descriptions and product documentation were checked as well as company departments such as production, packaging, storage and incoming goods.

• The client receives a detailed final report which highlights the potential gaps in their QM system.• Due to native speakers in the audit team it was possible to study the documents quickly and efficiently.• The client is now optimally prepared for the pending FDA audit.

Medical equipment manufacturer, Hungary

Activities

Client benefits

Project

Client

Implementation

« Our employees work independently and proactively. Our clients’ and their employees‘ workloads

in return are reduced. »

Angelika Buhndorf, Head of Unit Compliance and Documentation, EXCO GmbH

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Measuring & testing Safety test for IVD, laboratory or medical devices

Reference project

A client (test laboratory) completes tests for the conformity of ophthalmological diagnostic devices to current test standards. EXCO supports with the conformity assessment and completion of thetestaccordingtoDINENISO60601,edition3,forpreviouslylaunched systems compliant to older versions of the standard.

Accomplishment and documentation of tests to prove the device safety:

•Riskevaluation•Evaluationofusability•Visualexaminationforcompliancedocumentation•Creationoftestingrecords•Inspectionreports•Testreports•Technicalreports(CSA)•Checklists•Riskanalysis•Reviewingofriskmanagementdocuments (operation instructions or user manual, service manuals)

EXCO completes the required electrical measurements of devices as well as the mechanical tests. EXCO records the measurement results on basis of the standards assessment.

• Independent interpretation of the standard requirements and evaluation of devices test samples.• Relieving the department of its workload and increasing the capacities.

Market-leading independent test laboratory, Germany

Activities

Client

Project

Implementation

« Based on our continuous support, we enable our clients to increase their capacities. »

Thomas Wagner, ProjectManagerProcessQualification-MedicalTechnology,EXCOGmbH

Client benefits

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Trainings

EXCO is one of the market-leading providers of qualification and validation services for the medical technology and diagnostics sector in Germany. Quality assurance procedures,software and system development as well as automated testing in the regulated environ-ment represent the key areas in the range of services we offer. We are pleased to pass on our expertise to others.

As a company that is officially accredited by the „German Testing Board“ and the „Inter-nationally Certified Professional for Medi-cal Software Board“, we offer seminars and workshops which can also be concluded

with an optional certification test. In addition to this, the EXCO training program also encompasses basic and advanced training programs on Good Manufacturing Practice (GMP) as well as workshops on the topics of quality assurance and software testing rel-evant to secure environments. Software developers and testers, quality man-agers and project managers benefit from our lively, in-depth seminars and workshops, small class sizes, modern training facilities as well as our first rate technical facilities. We also offer in-house trainings.

Special training for developers and quality assurance experts in the medical technology environment

Dates and contents of current training offers:

www.exco-solutions.com/trainings

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As a global technical service provider for consulting, project management and turnkey solutions in the product, laboratory and production environment, EXCO offers customized project support from one single source.

1994

Frankenthal, Germany

>20millionEuros/year

>300

DINENISO13485,DINENISO9001

Corporate groups, leading manufacturers as well as systems providers from the medical technology, pharmaceuticals technology, biotechnology, food technology and chemical industry

ABB, Microsoft, SAP (extract)

Six locations in Germany and one location in Switzerland

Germany Switzerland

Facts and figures

Clients

Employees

Head office

Year of foundation

Turnover

Certifications

Locations

asofDecember2014

Partnerships

Contacts

Andreas HorchlerEXCO GmbH

+49 6233 [email protected]

Luis TejeroEXCO Consulting GmbH

+41 41 [email protected]

EXCO. The Quality CompanySolutions for Industry and R&D

EXCO GmbHAdam-Opel-Straße 9–11D-67227 FrankenthalT +49 6233 73778-0F +49 6233 [email protected]

EXCO Consulting GmbHD4 Business Village Luzern, Platz 5 CH-6039 Root LängenboldT +41 41 455 24 70F +41 41 455 24 [email protected]

www.exco-solutions.com

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