MedTech Academy
All things Medical Device and IVD development. At CLIN-r+ we believe in sharing knowledge so that manufacturers and innovators can bring great technology to healthcare. Here you’ll find the information you need for successful MDR/IVDR transition. If you’d like information sent directly to your inbox, make sure you join our mailing list.
What documents and resources are needed for performance evaluation requirements under IVDR?
What is involved in the performance evaluation process for IVDs under the IVDR?
We have...
- April 16, 2024
What are Orphan Medical Devices?
How are they regulated?
How does EU MDR impact orphan medical devices?
We explain all…...
- April 16, 2024
What are common nonconformities identified under the EU MDR?
What does a Notified Body want from your Technical Documentation?
What can mitigate risks and ensure compliance?
We have...
- April 16, 2024
Why is the "Intended Purpose" important for medical devices under EU MDR?
What are the key differences between "Intended Use" and "Indications for Use" for medical...
- April 16, 2024
What steps should be taken to prepare for compliance with EU MDR
How do you formulate a project plan?
How do you review Technical Documentation structure for...
- April 16, 2024
What is the difference between consultancies and agencies for Clinical Regulatory Affairs?
Should you work with an external agency or a consultancy?
We explain all…...
- April 12, 2024
Why do you need a systematic literature review?
What steps are involved?
What are some key reasons for non-conformances in literature reviews during audits?
We have the...
- April 5, 2024
What is a Quality Management System (QMS)?
Why is it important?
How does it work?
We have the answers to the questions and more…...
- April 5, 2024
What is the difference between claiming equivalence under EU MDR compared to MDD?
What are the key requirements for demonstrating equivalence?
What can improve the process of...
- April 3, 2024
What do you need to do after obtaining a CE mark?
What is involved in updating Technical Documentation post-CE mark?
We answer these questions and more…...
- April 3, 2024
Feedback from MDR regulatory submissions are valuable assets that we incorporate in our EU MDR transition projects and strategy documents for clients. CLIN-r+ shares the...
- February 13, 2024
This case study looks at remediating biocompatibility workflows to meet EU MDR compliance requirements. CLIN-r+ supported the manufacturer with their problematic biocompatibility workflows to address...
- February 6, 2024
