PROFESSIONAL QUALITY MANAGEMENT SYSTEM SUPPORT

About us

Vinga Medtech is located on the beautiful island of Hönö which is situated in Göteborg’s Northern archipelago.

A small consultancy company with Melanie Janbro at the helm. She has worked within QARA (Quality & Regulatory Affairs) since 2004, acquiring experience and competence during the years. She is a qualified Lead Auditor via Lloyds of London, is a member of the SIS Technical Committee (TK 355) for Quality Management Systems, Risk Management and other medical device industry standards and is originally from North Wales in the UK. She is a native English speaker and has excellent Swedish skills.

Working within the medical device and Life Science industries, all consultancy is performed within the frameworks of ISO 13485, ISO 9001, MDR/MDD & QSR.

Offering the following areas of expertise:

Developing

Developing, implementing and improving Quality Management Systems and technical documentation

Auditing

Internal auditing, supplier auditing, Post Market Surveillance and CAPA systems

Translation

Technical translation from Swedish to English
Östra Vägen 7, 475 42 Hönö, SWEDEN
+46 (0)702 963542
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