Medical Device Engineering, Testing, Regulatory Experts | 1

Medical Device Engineering, Testing, Regulatory Experts | 2Medical Device Engineering, Testing & Regulatory Experts | 2

INTRODUCTION

providing medical device development services to accelerate your product.

Over 35 years of experience,

Testing ClinicalRegulatoryEngineering MRI Safety CM&S Device Assembly

Scientific Communications

RegenerativeMedicine

Medical Device Engineering, Testing, Regulatory Experts | 3Medical Device Engineering, Testing & Regulatory Experts | 3

INTRODUCTION

MEDICAL DEVICE

EngineeringOur team has worked on hundreds of Class II and Class III medical devices.

We have an engineering team that can support new product development activities as well as regulatory approvals.

• Prototyping• Clinically Relevant Acceptance Criteria

and Boundary Condition Development• Test Method Development• Validation• Physiologic Model Development• Risk Analysis, Risk Mitigation

and Design Control Engineering• EFS Device Assembly• Post Market Evaluations

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INTRODUCTION

MEDICAL DEVICE

TestingWe have a portfolio of 250+ accredited tests and are actively validating new testing methodologies.

We cater our services to fit your needs, while considering the clinical, scientific, regulatory, and engineering perspectives before work beings.

• State of the art testing facility• 300–500 test capacity per year• ISO and ASTM standards• Good laboratory practices, since 1993• ISO 17025 accredited, since 2004• Pursuing ASCA accreditation

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INTRODUCTION

MEDICAL DEVICE

RegulatoryServices

Successful regulatory submissions start with strategic planning that begins early in the device development process.

• Development phase planning• Strategies for marketing approval• FDA advisory committee preparation • Post-approval responsibilities and

regulatory submissions at all phases• Biological Evaluation services

MED personnel have worked on 40 original IDEs, 12 FDA-approved original PMAs and 1 original NDA, including the PMA for the first FDA-approved coronary stent and the PMA for the first FDA-approved drug-coated peripheral stent.

EXPERIENCE

Partner with a dedicated team that can help you find your regulatory path through the development process and beyond.

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INTRODUCTION

MEDICAL DEVICE

Clinical ServicesReal-world experience, thoughtful guidance. We can help you understand when clinical data may be necessary and strategize how to collect them most efficiently.

We provide thoughtful guidance and quality clinical trial services to clients who require expertise in the efficient development of novel medical products and therapies.

• Our personnel has managed clinical trials with more than 2,500 patients at 50+ trial sites in 10 countries.

• Our team is cross-trained, with experience managing clinical trials within the engineering team, regulatory team, and business operations.

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MEDICAL DEVICE

MRI SafetyWe help medical device manufacturers evaluate their devices for safety and compliance in the MRI environment and perform physical MRI testing, such as:

• RF-induced heating (ASTM F2182)

• Magnetically induced force (ASTM F2052)

• Magnetically induced torque (ASTM F2213)

• MR image artifacts (ASTM F2119)

After the testing is complete, we provide the necessary information for MRI safety labeling and supporting scientific rationale that is reported in the instructions for use (IFU).• MRI Safety Information & Labeling (ASTM F2503)

Our engineers can perform physical MRI testing to evaluate the safety of your device in the MRI environment.

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MEDICAL DEVICE

Computational Modeling & Simulation

Our computer modeling and simulation (CM&S) capabilities can accelerate your product development, saving you time and money.

Our experts can provide a total solution for medical device development using computational modeling and simulation (CM&S), also known as computer aided engineering (CAE).

To optimize device design, we evaluate the performance and manufacturability of devices before physical prototyping using:• Topology/shape optimization

• Linear/nonlinear structural analysis

• Computational fluid dynamics/Fluid Structure Interaction

• Constant life curve/fatigue life evaluation

• Multiphysics simulation for RF-induced heating during MRI

• Modeling of biocompatible materials

• Metal forming

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MEDICAL DEVICE

AssemblyUnderstanding the challenges unique to producing devices for early clinical experience.

Our experienced and expert engineers understand the potential challenges that can come with producing medical devices.

• Process integrated with engineering, testing, and regulatory experts

• Assembly for:− Permanent implants− Delivery systems− Single use devices

• ISO 13485:2016 quality system

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INTRODUCTION

MEDICAL DEVICE

Scientific CommunicationsWe have expert scientific staff available that can:

Our expert scientific staff collaborate to support your medical and scientific writing needs.

• Thoroughly review, evaluate, and create clinical evaluation reports (CER)

• Assist with medical/scientific writing inpreparation of publications (e.g., when you are short on resources)

• Edit manuscripts to optimize suitability for submission to English language journals

• Prepare presentations and posters for scientific conferences

Medical Device Engineering, Testing, Regulatory Experts | 11Medical Device Engineering, Regulatory, and Clinical Experts | 11Our staff has extensive experience with combination products, tissue/biologics,

regenerative medicine, cellular therapy and tissue engineering therapies.

• Translational development and product validation

• In-vitro bench testing− Cell product characterization− Safety testing− Assay development

• In-vivo animal testing− Feasibility & GLP animal studies

Comprehensive solutions to unique and rapidly evolving pre-clinical challenges with cellular, tissue and gene therapy.

CELL AND REGENERATIVE MEDICINE

Pre-clinical RMServices

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OUR SERVICES

Concept Generation

I.P. Development& Prototypes

Feasibility Design V+V Design Control

Regulatory Filings

Clinical Approval/ Post-Market

Activities

Accelerated Product Development

Technical Patent Support

Computational Modeling &Simulation

Medical Device Testing

Boundary Condition Development

Design History File Regulatory Submission

Process Validation Testing

EFS Device Assembly

Surveillance

Design Prototyping

Regulatory Strategy

Design Iteration

Clinical Trials Regulatory Approval

MEDICAL DEVICE

Services

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OUR APPROACH

We collaborate with you and other experts.

CollaborativeApproach

InternationalStandardsCommittees

Safety &Effectiveness

Research

Client Projects(like yours)

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What can we do to help guide your project through the medical device product lifecycle?

Thank you.

Testing ClinicalRegulatoryEngineering MRI Safety CM&S Device Assembly

Scientific Communications

RegenerativeMedicine