Stina Johansen

Director Medical Device

Stina joined SDS in 2017 as the Director of the Medical Device business unit and Head of SDS Quality. Stina holds a PhD in Medical Biochemistry and a MSc in Biochemistry from Uppsala Universitet, Sweden. With her expertise in regulatory affairs, Stina is responsible for advising clients on both strategic and operational levels, particularly in product development programs involving medical devices alone or in combination with drugs. She also provides support to clients in obtaining necessary quality systems on their way to regulatory submission. Stina has 10 years of experience in the MedTech and Pharma industry and has held several leadership positions, including as a Technical Lead in a global project and as a Risk Management Process Owner. She is a subject matter expert on the following standards: Medical Device Usability IEC62366, Risk Management ISO14971, and Quality Management System for medical devices ISO13485. Stina also has expertise in performing GAP analysis (e.g. QMS) and providing training/seminars on QMS, RM, etc. Her experience includes a diverse set of products from working with clients in micro, small and medium-sized enterprises to large MedTech/Pharma companies.

Contact details:
stina.johansen(at)scanddev.se
phone +46 76 146 90 71