Erfa-gruppe 23: Medical Device Design Verification Testing

SPM network group 23 is a professional network for the exchange of knowledge and experiences within Medical Device Design Verification Testing.

Who are members of network group 23?

The members of network group 23 come from a broad representation of Danish companies – including both large and small Danish technology companies and advisory and test centers.

Access to knowledge, networking opportunities and professional literature  

Mechanical test equipment in R&D is typically not developed specifically for the pharmaceutical industry and thus often not compliant with requirements from FDA and other authorities. Based on this challenge, SPM network group 23 was formed.

The overall purpose of network group 23 is for members to meet and discuss challenges concerning test and test equipment validation, share experience to get a common understanding of requirements and practical solutions to comply with requirements.

The basic assumption is that the group members are the experts, with the best and most applicable knowledge and experience within the field.

It is our ambition that the network group becomes your personal space, where you can test ideas with likeminded professionals.

At the same time, you get access to SPM’s library of technical reports and professional literature.

Focus areas

FDA and other regulatory authorities’ requirements to Design Verification Testing in R&D with key focus on requirements to the test equipment
Risk level and the required controls, compared to e.g. equipment that measures the drug before shipment
Timing of DVT testing and criticality of different tests
Practical solutions regarding e.g. 21 CFR part 11, audit trail, access control and unauthorized access to the test data, separation of duty and limited access to system setup

 About the network group meetings

Network group 23 typically sets up half-day meetings in English and with changing host companies.

Example of an agenda

12.00-12.45: Welcome to Novo Nordisk and lunch
12.45-13.00: Planning of next meetings including topics, all
13.00-14.00: New Novo Nordisk SOP on the use of statistics in design verification testing, Novo Nordisk
14.00-14.45: Novo Nordisk laboratories tour
14.45-15.50: Rounds: Handling of ”validated range” for validerede testmetoder, all
15.50-16.00: Wrap-up

Contact co-ordinator

Co-ordinator for SPM network group 23 is Poul Hilding Andersson, Oticon, poan@demant.com

Join the network group here  

You can join SPM here.

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