Documents to download

Download - qtec files

Whether biocompatibility, risk management or checklists for the Essential Requirements: We have compiled numerous informative documents for you to download with the most important topics and facts about the approval of medical devices and co.

Regulatory Affairs

External PRRC Chart
Our chart "The PRRC at the manufacturer" gives you an overview.

Download


Ess. Req. CheckList - MDD V1 (docx)
Essential Requirement Check List - MDD

Download


Ess. Req. CheckList - MDR (docx)
Essential Requirement Check List - MDR

Download


Ess. Req. CheckList - MDR (xlsx)
Essential Requirement Check List - MDR

Download


In-House Medical Devices in Europe (PDF)

Download


Transition from MDD to MDR (PDF)
Expiration of Certificates

Download


Poster Regulatory Affairs Manager (PDF)

Download


Biological evaluation

Poster Biocompatibility Expert (PDF)

Download


Qualitity Management

Ess. Req. CheckList - MDD V1 (docx)
document with the essential requirement checklist pertaining to the MDD

Download


Poster Quality Manager (PDF)

Download


Blog

AET - What is it?
The AET is an essential component for the biological safety assessment of the chemical characterisation of leachable substances in medical devices. Read details about the AET here.

Download ( DE ) Blog


qtec Academy

English Training Brochure

The qtec Academy offers you a wide variety of training options to find the right format for you. From in-person seminars to online seminars and in-house training.

Download EN


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