QA and Testing in Medical

Devices

Kristof Horvath and Sandor Szabo

8 April 2015

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QA and Testing in Medical Devices

Webinar info

• Live demonstration will be followed

by a Q&A session

• Webinar recording will be available

at http://intland.com/webinars/

• Please register to our upcoming

webinars

• SAFe Configuration Example on 29

April 2015

3

Agenda

1. Medical device safety

2. Industry regulations & standards

3. Safety & process quality requirements

4. Live demo of codeBeamer ALM

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o Founded in 1998

o Headquarters in Stuttgart, Germany

o Office in Silicon Valley, USA

o Partners in Korea & Taiwan

o codeBeamer ALM with features

including:

• Requirements Management

• Software Development Management

• QA & Test Management

• Demand Management

• IT Operations (DevOps)

Intland Software

Who are we?

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Our Clients

Automotive

High Technology

Defense

Finance

Medical

Other

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Patient safety is by far the most important aspect when designing and manufacturing

medical devices

In developed countries about 10% of patients is harmed by medical errors (WHO)

Many of these errors are caused by medical device failure

Errors in medical devices harm patients and manufacturers alike (through model recalls)

Medical device recalls increased in numbers in the last 10 years

Large percentage of recalls are caused by software failure

QA and Testing in Medical Devices

Medical device safety

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QA and Testing in Medical Devices

Medical device recalls in recent years

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• 2 Industry standards influencing the manufacturing of medical devices:

• IEC 62304 – Medical device software lifecycle processes

• ISO 14971 – Application of risk management to medical devices

QA and Testing in Medical Devices

Industry regulations and standards

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QA and Testing in Medical Devices

Overview of standard IEC 62304

• Software development plan

• Software requirement analysis

• Software architectural design

• Software detailed design

• Software unit implementation and verification

• Software integration and integration testing

• Software system testing

• Software release process

• Software maintenance plan

• Problem and modification analysis

• Modification implementation

• Software risk management process

• Risk management of software changes

• Software configuration management process

• Software problem resolution process

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QA and Testing in Medical Devices

Industry regulations and standards

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QA and Testing in Medical Devices

Overview of standard ISO 14971

• Assignment of risk management responsibility

• Risk analysis

• Risk management file

• Documenting intended use of system

• Residual risk analysis

• Post production report

• Monitor system in production and post production

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codeBeamer Live Demo

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Thank you for your attention!

How to Integrate Git, SVN and Mercurial into ALM15 Apr 2015

4 PM (CET) / 11 AM (ET)

http://intland.com/webinars-events/

Any questions?