About

About Us

 

Consultants

Regulatory Affairs Consultant

Micael Johansson

Senior Consultant QA/RA

Medical Devices


 

Tel +46 73 070 10 44


Micael is the company director at MEDQURE CONSULTANCY and a senior regulatory affairs consultant. He consults to startups and large companies in Europe. He is currrently serving on the boards of MEDEA and is Chairman of the board at Apotekarsocieteten. Micael is a member of the standard comittee TK62 & TK66. (TK62 handles the EN 60601-series and TK66 handles the EN61010-series)


Micael is a co-founder at MEDQURE, a training academy offering courses in Regulatory Affairs and Standards. As an instructor he holds a number of courses in Denmark and Sweden.

Regulatory affairs consultant

Susanne Grimsby

Senior Consultant QA/RA

Medical Devices

 

 

 

Susanne is certified in medical device quality management and regulatory affairs. Well experienced in the establishment and maintenance of quality management systems for medical devices and in the application of standards such as ISO 13485, ISO 14971 and IEC 62366. She has practical experience with CE- Marking of both MD and IVD products. Also, she has a deep knowledge of regulatory requirements, IVDD 98/79/EC and MDD 93/42/EEC, and is familiar with the new regulations, IVDR and MDR. Extensive experience also includes product development and project management.

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00 46 730 70 10 44