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

2© Perforce Software Inc. All Rights Reserved.

Presenters

Nico KrügerTechnical Solutions Engineer

Ann RossiSr. Software Quality Assurance Manager


Introduction

Fractyl is a clinical-stage medical technology company developing innovative procedures and devices to address

insulin resistance and restore metabolic health.


• 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


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)


• 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


• IEC 62304: Software Life Cycle for

Medical Devices

• ISO 14971 Risk Management

Medical Device Compliance


FDA Design Waterfall Process

User Needs

Design Input

Development Process

Design Output

Design OutputValidation

Clinical Trials

Verification

Design Review


• 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


• 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)


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


• Sample of what Regulatory Agencies are looking for…

Trace Matrix


Traditional Trace Matrix


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


• 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


Helix ALM – Requirements Module


• Requirements by Release

Developed a Folder Structure


Issues Module


Test Case / Test Runs


• We use this in our Verification Summary Report that is submitted to regulatory bodies.

Software Trace Matrix(Direct from Helix ALM Reporting)


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


Risk Management ComplianceFMEA – Risk Management Tool


Helix ALM System Use SOP

Helix ALM System

Use SOP


• 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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Perforce user webinar fractyl dhb jb_dhb_adr edits

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