General Safety and Performance Requirements (GSPR) Checklist

Designed to support your conformity to Annex I of MDR 2017/745, this document contains a full table of MDR general safety and performance requirements as well as a list of Applicable Standards.

Designed to be easy to use and follow, the template will save you many hours, headaches and potential mistakes. 

This MDR GSPR checklist is a mandatory document, required during the evaluation of your conformity. The template provides an overview of all elements required to prove this compliance, and is required for all classes of products, including:

• Class I  /  Class Ir  /  Class Is  /  Class Im  /  Class IIa  /  Class IIb  /  Class III

• Custom-made devices

• Drug product with a Medical Device

The template will provide you the information you should have on your technical file and will give you some examples of what you should fill on it. In the case of questions you can still reach out by email.

Note: Previously, in MDD 93/42/EC, this was called the “Essential Requirements”

Benefits:

• Use the template for all your products

• Flexible word design, suitable to your organisation

• Over 500 hours have gone into the development and refinement of this template

• Includes table of applicable standards and all current GSPR

• Start using it right away, today

Format: Microsoft Word (2010/2013/2016)

Language: English (others available on request)

Disclaimer: After purchase this product is not subject to reimbursement