This template allows you to :
✔️Access a complete list of In-Vitro Diagnostic Medical Devices standards (ISO, CLSI...)
✔️Access a list of evidence requirements for each GSPR
✔️Access a pre-defined methodology to ensure compliance with each of the GSPRs.
45 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 IVDMD.
→ 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 (PEP, PER, SVR...)
→ Write your GSPRs clearly, concisely and precisely
✅ Comply with the requirements of Annex I of the IVDR 2017/746
GSPRs are a real road map for writing your technical documentation AND ensuring compliance with IVDR 2017/746.
Start on the best path with clear and compliant GSPRs. Here is a brief summary of the link between GSPRs and your IVDMD's technical documentation:
Access a complete framework/template for documenting your GSPRs in accordance with Annex I of IVDR 2017/746. For each GSPR: access a list of standards, a list of expected documents and a pre-written methodology.
Use this template as a guide from the start of your project.
45 pages, available for immediate download
The template may evolve based 2017/746 requirements. Once in your possession, you will receive updates free of charge.
Here is an example taken from the template with GSPR 9.4