Regulatory barriers often have significant influence on the success of product ideas.
– But which ones should you pay attention to first, and why?
Medical devices take a variety of forms and functions, and it takes both specialist- and leadership experience to navigate the complex set of requirements in force world wide. With experience in development of a variety of medical device and combination products, including start-up companies, I can contribute significantly to a successful startup of your new project.
I am specialized in writing complex product applications and clinical evaluations, and know by experience, which documentation is needed as evidence for the safety and effectiveness of medical devices and device/drug combination products.
Fell free to contact me for an informal discussion of your next project.