Determination of regulatory strategy
The regulatory strategy provides answers to questions such as:
- Is my product a medical device? How do I have to formulate the intended purpose in order to achieve or avoid qualification as a medical device?
- What class does my medical device fall into? How do I have to formulate the intended purpose in order to achieve the desired classification?
- Is my product a medical device or accessory?
- Do I have to have the entire product approved as a medical device or can I also put modules on the market as medical devices?
- Should I make use of the transition periods of the MDR or IVDR? When is it recommended to do so?
- What should I pay attention to when choosing the Notified Body?
- Should I set up my own QM system or is it better to use the QM services of a legal manufacturer?
- How can I save my previous PLM-OEM construct under the MDR or IVDR?
- Should I start in Europe or the USA first? Can I reuse the documents?
Our regulatory affairs experts work with you to develop the regulatory strategy.
Implementation of the regulatory strategy
The Johner Institute helps you to implement your regulatory strategy:
- Classify your product
- Formulate the intended purpose
- Select a notified body
- Compile a list of the required documents
- Create these documents (e.g. technical documentation)
- Communicate with notified bodies
- Select lawyers in case of disputes
- Review documents before submitting them
- Manage the project