QMS Implementation for Class III Medical Device
Introduction
Streamlining ISO 13485 Certification for a connected medical device.
The company is a highly innovative start up, which has developed a best-in-class pacemaker. At the time of engaging with them they were on the road to CE Marking.
Apotech Team
- Worked full time on the project: balanced position between coaching the internal team and being hands on when required
- Prepared the QMS backbone
- Supported the team in Authoring the SOPs
- Organised and led the Risk Assessment workshops
- A second consultant acted part-time as a sterilisation SME: supporting the client’s Team in their sterilisation process (ETO)
- Risk assessment, SOPs writing, provider management (Quality agreement).
Standards & Tools
- EU-MDR 2017-745
- ISO 13485
- ISO 14971
- ISO 11137
Scope of work
QMS writing and implementation
Training on QMS implementation
Notified bodies relationship
Risk assessment
Sterility insurance
The project was focused on the design and development activities.
Key numbers
Team
1.5 FTE
Location
France
Length
12 months
Type
Time and Material
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