Regulatory Affairs

Camilla Wamberg Munkesø offers expertise within the following tasks:

Regulatory Strategies for medical devices and combination products. Especially, I have experience assisting start-up companies.

Regulatory specialist work e.g. premarket approvals: CE marking, IDE/PMA, 510(k) etc.

Clinical Evaluation of your medical device, in compliance with EU MEDDEV 2.7/1 revision 4.

Experience with many different start-up companies – ISO 13485 and ISO 9001 implementation and management.

Varoius Regulatory assignments- please contact me.

Please contact me on: +45 40186423 / email: info@deviceadvice.dk