perforce user webinar fractyl dhb jb_dhb_adr edits
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From Word Docs to Compliance:
How Fractyl Achieved CE
Certification in Record Time
Nico Kruger, Technical Solutions EngineerPerforce Software
Ann Rossi, Sr. Software Quality Assurance ManagerFractyl Laboratories, Inc., Lexington MA
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Presenters
Nico KrügerTechnical Solutions Engineer
Ann RossiSr. Software Quality Assurance Manager
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Introduction
Fractyl is a clinical-stage medical technology company developing innovative procedures and devices to address
insulin resistance and restore metabolic health.
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• Fractyl has created the RevitaTM duodenal mucosal resurfacing (DMR) System, an investigational, minimally invasive, same-day clinical procedure. It’s designed to address the intestinal cause of insulin resistance and restore metabolic health in patients suffering from metabolic diseases, such as Type 2 Diabetes.
Introduction
RestoreThe lining of
the duodenum
ImproveInsulin resistance and
metabolic health
CorrectAbnormal hormonal
signaling and nutrient absorption
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Agenda
1
Medical Device Compliance Overview
2
Our Problem(s) to Solve
3
How we used Helix ALM to obtain Compliance with IEC 62304 (SW)
4How we drove to compliance with
FDA and ISO Medical Device Quality System Regulations
(Including Risk Management)
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• ISO 13485: International standard for
medical device quality systems
• FDA Quality System Regulation (QSR)
• Based on ISO 13485
Medical Device Compliance
ISO 13485:2003 and FDA Quality System Regulation
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• IEC 62304: Software Life Cycle for
Medical Devices
• ISO 14971 Risk Management
Medical Device Compliance
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FDA Design Waterfall Process
User Needs
Design Input
Development Process
Design Output
Design OutputValidation
Clinical Trials
Verification
Design Review
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• We had the procedures to comply with the Quality Management System Regulations…
• Product Development Procedure
• Software Development and Maintenance Processes
• Software Problem Resolution Procedure
• Risk Management Procedure
• BUT we needed an electronic system to simplify things.
Procedures
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• Many requirements that we needed to organize with unique identifiers.
• We needed to comply with Medical Device Quality System Regulations (FDA and EU).
• We needed to assure that we had traceability from the requirements to design verification tests, and associated issues.
• Use of requirements traceability enables product development teams to attain a level of project control, quality assurance, and product safety that is difficult to achieve by any other means.
The Problems to Solve (Immediate Needs)
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Traceability
“In the most common form of the traceability matrix, the input requirements are enumerated in a table, and references are
provided to each section in the output documents (or software modules) which address or satisfy each input requirement.”
- From the FDA
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• Sample of what Regulatory Agencies are looking for…
Trace Matrix
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Traditional Trace Matrix
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How to Find the Solution
• Having continuous
improvement through this
problem solving process
is best practice in any
industry.
Identify andDefine theProblem
Analyze theProblem
IdentifyPossibleSolutions
Select andPlan theSolution
Implementthe Solution
Evaluatethe Solution
ProblemSolving
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• We had requirements and tests in Word documents.
• Software issues were in Jira; others were captured in Word
documents.
Where Our Quality System Started…No Easy Way to Trace
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Helix ALM – Requirements Module
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• Requirements by Release
Developed a Folder Structure
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Issues Module
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Test Case / Test Runs
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• We use this in our Verification Summary Report that is submitted to regulatory bodies.
Software Trace Matrix(Direct from Helix ALM Reporting)
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Hardware Team Jumped on the Bandwagon
Design and development planning
Design Verification
Risk analysis and preventive action
Design Validation
Design processphases and
reviews
Design Inputs
CustomerNeeds
Design Outputs
Product
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Risk Management ComplianceFMEA – Risk Management Tool
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Helix ALM System Use SOP
Helix ALM System
Use SOP
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• December 2010
• Fractyl began as a two person company.
• August 2014
• Fractyl received ISO 13485 2003 Certification.
• June 2016
• Fractyl received CE Mark.
• September 2017
• Fractyl received ISO 13485 2016 Certification.
Compliance Timeline
Questions?Thank you very much for your attendance!
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