SALIN CONSULTING



| IVD |
| Medical Devices |
| Quality Management |



Services and expertise



Our knowledge to the service of your Medical Devices.





Medical Devices European Regulation Implementation



We are here to support you in the implementation of the following regulations:

  • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.
  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.


Redaction and Verification of Technical Documents



We make sure that your documents will be compliant with the following directives respectively for In Vitro Diagnostic (IVD) and general Medical devices :

  • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.
  • COUNCIL DIRECTIVE 93/42/EECof 14 June 1993.


Implementation of Quality Management System



Our commitment to quality is at the heart of our practice and we will be with you through every step for Implementation of Quality Management System compliant to:

  • QMS following ISO 9001:2015
  • QMS following ISO 13485:2019 for medical device producer


Additional services: Risk, Audits, Workshops, ...



  • Workshops In House listed Topics
  • External and Internal Auditor Services
  • Preparation for Audit with competent authorities
  • Risk Management system and files verification
  • Counsel and analysis on In Vitro Diagnostic for medical device manufacturers.


About Us





"Qualität ist das Produkt der Liebe zum detail" A.Tenzer



Owner and Founder - Marie Salin


Marie Salin is an experienced Managing Director with a demonstrated history of working in the medical device industry. Skilled in Medical Devices, Sales Management, Biotechnology, Management, product development and registration.


Expert of the european market and medical regulations of the territory, Marie is fluent in German, French and English.



Contact us, we can't wait to assist you.



We are based in Wiener Neustadt, Austria.








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