Images

From idea to product

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.

Camilla

On track with MDR

The MDRs comes into force in May 2021. I suggest to pay focus to the following areas in particular:

  • Will your Notified Body remain active in your therapy area when the MDR comes into force? If not, it is time to engage with a notified body that does.
  • If you are a manufacturer of In-Vitro Diagnostic Medical Devices (IVD) you might have a change of classification to a higher risk class in your product portfolio which  requires a re-certification of the products.
  • Is the distributors and importers of your devices made aware of their responsibility, and are they controlled according to the requirements in MDR (17/745) Article 14?

Contact me if you need more information, or would like a gap-analysis of you current products and quality system in relation to the MDRs.