Frank Matzek serves as the Vice President Regulatory & Governmental Affairs at BIOTRONIK in Berlin, Germany. BIOTRONIK is a leading global medical device com­pany with products and services that save and improve the lives of patients suffering from cardiovascular and endovascular diseases.

Frank holds a Dipl.-Ing. degree in biomedical engineering from the Technical Univer­sity of Berlin, is a certified quality engineer and has received a degree in business and administration from VWA Berlin.

In addition to his role with BIOTRONIK, Frank is actively involved in the industry associations MedTech Europe and BVMed Germany as a member/vice-chair of various core teams, work groups and committees.

Specialized in EU regulatory issues relating to medical devices, including eHealth, mHealth and protection of personal data. Active in law and policy development as a committee member of branch associations and the European Commission.  

Axon lawyers focused on legal and regulatory aspects on the life sciences sector. 

Through the Program Office for ACT, Johansson has oversight of all projects within ACT aiming at innovation, R&D and EU MDR implementation.  

Holding a Master of Science in Industrial Engineering and Management. Johansson has held several senior leadership positions: VP for various functions for Critical Care in Sweden, Managing Director for the Advanced Monitoring business, and the Cardiopulmonary business within ACT in Germany. 

Responsible for communication with Getinge's Notified Body and the transfer of all Getinge companies to the same Notified Bod, and the MDR implementation program. 

Holds a Master of Science degree in Technical Physics with a Medical Engineering degree with more than 25 years of experience in medical technology from Siemens-Elema and Getinge. He has worked with class l to class lll products during all phases of the product life cycle.