noaQA

Country headquarter:
Denmark.
 
Market presence:
All European countries, USA, Canada and Australia.
 
General description:

I am a Regulatory Expert within Medical Devices, that helps companies to find the regulatory pathway for the market where the company wants to place their products. This includes product certification according to MDD in Europe and FDA clearance according to FDA 510(k) in USA.

The products can be medical devices or software like Apps where I have extended knowledge regarding compliance within e-Health. Together with the companies I establish a Pragmatic Compliance that is essential to establish a competitive market driven regulatory strategy. I also establish and maintain quality procedures and implementing processes related to Risk Management, Usability, Software Development, Electrical Safety etc.

Areas of regulatory/reimbursement support:

Market and regulatory knowledge within apps used in Healthcare, Mobile Health, eHealth etc.; Is your app a medical device?; What regulations are applying to your Apps, and consequently the work to be done; How do the regulations affect your development process with focus on time to market and cost?; CE marking in Europe, FDA-clearance USA.

Company website