Regulations for medical device software

What applies to software in medical devices? The Support Office for Life Science and Health, SOLH, invites you to a digital seminar that provides an insight into the rules and requirements that apply to software in medical devices. Lecturer is Roger Isberg from Medos.

The seminar open to anyone interested in regulations for software and medical devices

Program

13.10-13.25 Presentation av Support Office for Life Science and health/medtech4health, UBI, Uminova innovation/EEN

13.30- 15.00 Digital presentation MDR

15.00-15.10 Digital Q&A session in plenary

15.10 15.20 Break

15.20-16.20 Digital presentation about software specifically

16.20-16.30 Digital Q&A session in plenary

Areas and topics that will be covered are the following:

General MDR (1,5 h) 

•  Introduction to medical devices and CE-marking
•  Qualification and classification (annex VIII)
•  Conformity assessment procedures (article 52, annex IX, X, XI)* General safety and performance (annex I)
•  Risk management (ISO 14971)
•  Clinical evaluation (chapter VI, annex XIV, XV)
•  Technical documentation (annex II)
•  Quality management system (article 10, ISO 13485, Focalcube)
•  Post-market surveillance and vigilance (chapter VII)
• Information for use and labelling (ISO 15223-1, ISO 20417, UDI article 27)
•  EU deklaration of conformity (annex IV)
•  Person Responsible Regulatory Compliance (PRRC)
• EUDAMED
• Guidance documents (MDCG)

Medical device software development (1 h)

• Introduction to medical devices and CE-marking
• Qualification and classification of medical device software (MDCG 2019-11)
• Software development and maintenance (EN 62304, Scrum)
• Configuration and change management
• Software architecture and detailed design (EN 62304)
• Technical documentation
• Risk management of software (TR 80002-1) Innovation key success factors for medical device software

www.medos.se

Sign up

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As the event is getting closer, the participants will recieve an email with a link to the digital meeting. 

Organizer

Support Office for Life Science and Health, SOLH, aims to support research and development in Life Science and Health and investigate the forms of a sustainable support structure in northern Sweden. The project has been coordinated by Umeå University's Innovation Office and carried out together with the EU project office at Region Västerbotten, Luleå University of Technology and Umeå University Holding with funding from Umeå Municipality and the European Regional Development Fund, ERDF.