Karin Westermark

Welcome to RegSmart, Karin Westermark, senior consultant medical devices

Welcome Karin Westermark!

On February 1, you joined our team as senior consultant in medical devices.

What is your background, prior to joining RegSmart?

Most recently, I worked at the Medical Device department at the Swedish Medical Products Agency (MPA) for six years – first as Assessor and the last three years as Senior Assessor – responsible for in-depth investigations of market surveillance cases. I was also active in the process of implementing the new Medical Device Regulation (MDR) as well as the In Vitro Diagnostic Regulation, IVDR from the authority. I served as Sweden’s representative in the EU Commission’s group for the Unique Device Identifier, UDI. 

Prior to that, I held different positions at Galderma, a manufacturer of medical device, pharmaceuticals and cosmetics, for five years. I was part of the Medical Affairs team, first as manager of the Medical Science and Information group, then as an expert.

My scientific background is in the fields of physics, biology and chemistry. I did my PhD in surface physics and electrochemistry at the University of Uppsala in May 2001. After this, I started working at Gammadata Scienta – now Omicron – a company developing and manufacturing surface analysis instruments such as electron spectrometers. I was there for five years at various positions, among them manager and technical expert.

I have also held the role as investigator the Swedish Radiation Safety Authority for five years, responsible for information, regulation and supervisory guidance for ultraviolet radiation and cosmetic lasers.

What are your strengths? How do you contribute?

Well, I think I have good analytical skills and extensive experience of assessing, summarizing and communicating information. I am used to working under time pressure and creating an overview of large amounts of data and drawing conclusions. I also like to set and reach goals.

I am driven by constantly learning new things, where I can add knowledge and perspectives from my previous experiences.

What are you looking forward to at RegSmart?

I am looking forward to sharing my knowledge and broad regulatory expertise within medical device – to the benefit of customers, patients and healthcare.


Karin´s experience within medical devices will be a great contribution to broaden the competence and expertise within the RegSmart team!