Informational VDI 2017 - Medical Grade Plastics - German VDI has published a "Richtlinie"

Wolf.K

Quite Involved in Discussions
#1
Hi,

The German VDI has published a "Richtlinie" (i.e. standard) called "medical grade plastics".

VDI 2017 - Medical Grade Plastics (MGP)

Contents
1. Scope
2. Terms and definitions
3. Abbreviations
4. Definition of "Medical Grade Plastics"
5. Regulatory requirements of Medical Grade Plastics
6. Consistency of formulations
7. Security of supply
8. Change management
9. Packaging, storage and logistics
10. Client-supplier relationships
Annex
A1 Example of a quality assurance agreement
A2 Risk assessment questions
A3 Examples of conformity assessments for MGPs
A4 Risk factors during processing

This might be interesting for all of us developing new MDs! As many suppliers use "medical grade" as a marketing tool - maybe we should start to ask them if they have heard of this German standard?

Truly yours,
Wolf
 
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