A key component of your success in the EU is to start out with a solid strategy for regulatory compliance. In fact, one of the manufacturer’s obligations defined in Article 10(9) of the EU Regulations is to develop such a strategy and to show how you will maintain regulatory compliance throughout the post-market phase. Whether or not you are already compliant with the EU Regulations, having a clear strategy for regulatory compliance will be vital.
Specculo can put together a Regulatory Strategy which may include the following:
- Device Qualification and Classification.
- Conformity Assessment Procedure.
- Specific Manufacturer Obligations.
- Technical Documentation Strategy, including:
- Risk Management Procedure.
- Clinical / Performance Evaluation.
- Post-Market Surveillance Procedure.
- Applicable Standards / Guidance.
- Labelling and IFU.
- Quality Management System Strategy.
- CE Marking and Notified Body Approval.
- Selling in the EU.
- UDI and Basic UDI-DI.
- EUDAMED Registration.
- Training and Regulatory Updates.
The process for developing your regulatory strategy will begin with an initial meeting to determine your needs and device portfolio. We will then use this information to create a Regulatory Strategy document which provides information and suggestions which will eventually lead you to obtain or maintain your CE or UKCA mark. A follow-up meeting can then be set up to discuss this strategy and work together into realising it.
What you get with Specculo
We have years of experience in handling large and small projects alike on a vast range of medical devices and IVD technology.