Uncategorised

Welcome to the SGS Munich Competence Center. In our test laboratories in Puchheim near Munich as well as Gelting and Rosenheim, we provide state-of-the-art testing and simulation facilities on an area of over 10,000 square meters.
SGS is the world's leading inspection, verification, testing and certification company.

First SGS Fimko MDR Certificate for German manufacturer

New IMDRF publication: Guidance on Medical Device Regulatory Review Report contents

New guidance document published on the implementation of the vigilance requirements of the Medical Devices Regulation (EU) 2017/745: Questions and Answers on vigilance terms and concepts

Update: list of harmonized standards under Medical Device Regulation (MDR)

Update of Quality System Regulation with Requirements of ISO 13485:2016

Disclosure of Standard Fees of Notified Bodies

The deadline for MDR certification has been extended: what’s next?

Devices without medical intended purpose according to MDR (EU) 2017/745 Annex XVI

SGS at MEDICA 2022 in Dusseldorf / Germany (November 14 - 17)

IEC 62368-1 Global Implementation Overview

IEC 60601-1 Ed. 3.2 (Amendment 2)

Patient monitoring

Household appliances, electric toys, and power tools

Household appliances, electric toys, and power tools – an excerpt from our test spectrum

Measuring, control, and laboratory equipment, as well as products for in vitro diagnostics (ivd)

Measuring, control, and laboratory equipment – an excerpt from our test spectrum

Product safety of measuring, control, and laboratory equipment

Out of hospital – SGS Munich offers complete testing according to IEC 60601-1-12

Medical devices – cybersecurity

Medical devices – links & downloads