aligning qms and engineering processes in medical product ...€¦ · 23/10/2019 aligning qms and...
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23/10/2019
Aligning QMS and Engineering Processes
in Medical Product Development
Szabolcs Agai, Functional Safety ExpertIntland Professional Services
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Agenda • When QMS meets Medical Software Engineering
• Current practices and challenges
• Typical use cases across medical compliance
• A brand new solution for easy and fast adoption
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• Company founded in 1998, HQ in Stuttgart, Germany
• Active in safety-critical markets for over 10 years
• Products and processes certified by TÜV Nord and TÜV Süd
Who we areIntland Software & Medical Device Developers
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QMS meets ALM
Engineering team QA team
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Current Practices and Challenges
• Isolated data islands• Fragmented, randomly redundant data• Low data integrity
• High effort to get management information• High cost of ownership• High exposure to human error• Lack of real traceability
Task Management
Document sharing
Requirements Management
QMS
Documents in
Wiki
MS Word
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Medical Software Engineering TemplateChallenges & Compliance
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Intland RetinaALM + eQMS is the solution
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Medical QMS Process framework
Good engineering practices
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Our Medical Templates support the development of:
US FDA: Software as a Medical Device (SaMD)
EU: Medical Device Software (MDSW)
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Intland RetinaValues
Analyze patient safety concerns
Intland Retina is a software platform that enables medical software development organizations to:
Save time and ensure quality to deliver safe and best in class
medtech software
Minimize the burden of dealing with administrative tasks
Deliver consistent design and development content for regulatory purposes
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1. ALM and eQMS for MedTech Engineers
2. Designed and validated by industry experts
3. Easy to use, intuitive user interface
4. Highly configurable, flexible to your processes
5. Guaranteed and automatic traceability
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Intland RetinaProcess approach
Pre-built process templates
• Medical Software Engineering• Medical Audit and CAPA
management
Custom tailoring • Additional and Custom Use Cases
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Medical Software Engineering TemplateKey supported processes
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Medical Software Engineering TemplateTemplate approach
• R&D Manager• Product manager• Development lead• Clinic fellow• Product risk analyst• Architect• Requirement engineer• Software developer• Verification and
validation engineer• etc.
• Medical software development planning
• Change Management• System design and product
risk management• Requirement engineering• Lifecycle product risk
management• Verification and Validation• Documentation
management• Software of unknown
provenance management• Legacy software
management• etc.
• User Requirement Specification• System Requirement• System Architecture• Risk Analysis and Evaluation• Risk Control• System Product Risk
Requirements/Mitigation• Software Requirements• Software Architecture• Software Design Specification• System validation protocol• SW/HW integration protocol• Software integration protocol• Software unit verification protocol• Test reports• etc.
User roles Workflows Data containers
Preconfigured
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Medical Software Engineering TemplateTemplate approach – Logical Data Model
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Medical Software Engineering TemplateTemplate approach – Information synthesis
DataData
DataData
DataData
DataData
Data
Data
Data
Data
Data
Information
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Medical Software Engineering TemplateTemplate approach – Information synthesis (Role-based dashboards)
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Medical Software Engineering TemplateTemplate approach – Information synthesis (Full lifecycle-wide traceability)
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Medical Software Engineering TemplateProduct Risk Management – Gapless traceability
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Medical Software Engineering TemplateDevelopment process management – V-model, Waterfall
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Medical Software Engineering TemplateProduct Risk Management - Agile
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Medical Software Engineering TemplateeDocument management – Part11 compliance
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Medical Audit and CAPA managementScope
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VISIT US AT
https://intland.com/retina/medical-device-development/
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