Welcome

I help medical device and drug companies getting their medical devices or combination products on market on time. In the past 12 years I have had a leading role in the medical technology industry within the fields of Regulatory Affairs and Quality Management.

How I work: I grasp the overall picture of complex projects and plan accordingly. I have experienced that complex projects succeed when starting out by defining a regulatory strategy identifying which data to invest in and when to do it. Involving main stakeholders – typically marketing and R&D in the strategy work is key.

I have a trained eye for catching main risk areas where resources should be focused in order to make it on time.

Start-up companies: I believe that simple, risk-based quality management processes are crucial to support the development and business goals of a typical start-up company. Without this experience and way of working the result often gets too complex and in-efficient. I am very keen on working with start-up companies because I feel I contribute significantly to the success of the company.

How can I help:

    • Successful definition and execution of regulatory Strategies
    • CE marking of medical devices and machinery
    • Scientific writing/medical writing: clinical evaluation reports (CER) and various regulatory documentation
    • World Wide approvals of Medical Devices in all risk classes
    • Regulatory requirements for device/drug combination products
    • New Medical Device Regulation gap-analysis and implementation
    • ISO 13485 certifications

Based in the capital region of Denmark,   I serve as a flexible and experienced partner for market leaders as well as entrepreneurs and startups.

See my CV for more details on my experience, education etc.

Please contact me on email or phone: CWM@deviceadvice.dk /

+45 40186423 to see if I can assist You in reaching Your goals!

Best Regards,

Camilla Wamberg Munkesø