Medical Device Clinical Development Planning
What is Clinical Development Planning?
Clinical Development Planning provides the master roadmap to develop and get CE accreditation for your Medical Device.
The clinical development plan outlines how you will gather enough clinical data for a subsequent clinical evaluation. It is the initial stage of the overall clinical evaluation plan.
We have a team of seasoned experts to support the strategic planning of the development of your device.
What do you need to be compliant?
CLIN-r+ recognises that the EU MDR requires more documents and a key one of those is the Clinical Development Plan (CDP). We can create this valuable strategic document to assist you in aligning development and regulatory requirements. Our team also ensures alignment with your Clinical Evaluation and Post Market Follow Up and our strategic services provide clients with the path for their device to be viable in the marketplace.
How can Clin-r+ help?
Our experts perform gap assessments to outlines what is needed for compliance. As each client and device is different, we can then tailor the support and services we provide such as technical documentation remediation for legacy devices which could include new design inputs and subsequent outputs, validation and verification records and addressing additional requirements of the GSPRs.
We evaluate risk and ensure you stay compliant with documentation, testing, and any other activities to keep you audit and regulatory submission ready while your internal product development teams concentrate on innovating the best device possible.
CLIN-r+ also has a wealth of resources for device classification, CE marking conformity requirements, GSPR checklist, validation master plan, updated labelling and IFU requirements as well as QMS system remediation needs for audit readiness.
Need more details?
We are here to assist. Contact us, set up a meeting, join our mailing list or follow us on LinkedIn.
You can also check out these white papers on our MedTech Academy:
