This template allows you to :
✔️Access a complete list of medical device standards
✔️Access a list of evidence requirements for each GSPR
✔️Access a pre-defined methodology to ensure compliance with each of the GSPRs.
77 pages, digital download (.docx)
The following is a sample page, which is part of the template
→ Determine for each GSPR whether it applies to your medical device.
→ Be inspired by the harmonised standards / standards & common specifications we recommend you use (or use it as checklist)
→ Be inspired by our list of evidence for the answer to each GSPR (or use it as checklist)
→ Be inspired by & adapt the methodology (or use it as checklist)
→ Ensure that you have a robust list of documents
→ Write your GSPRs clearly, concisely and precisely
✅ Comply with the requirements of Annex I of the MDR 2017/745
GSPRs are a real road map for writing your technical documentation AND ensuring compliance with MDR 2017/745.
Start on the best path with clear and compliant GSPRs. Here is a brief summary of the link between GSPRs and your device's technical documentation:
The template may evolve based 2017/745 requirements. Once in your possession, you will receive updates free of charge.
Here is an example taken from the template with GSPR 12.2
And here with the GSPR 18.2