Our IVDR Services
Celegence is a global life science consulting firm focused solely on regulatory and quality compliance. We have the expertise to provide support for all of your In Vitro Diagnostic (IVD) regulatory needs; from strategic consulting, registration, device classification, PERs, to in country representation.
IVDR Timeline
With the IVDR rapidly approaching now is the time to prepare. In Vitro Diagnostic manufacturers in the European marketplace need to develop and implement strategies in order to be fully compliant. They will otherwise face resource challenges if preparation is left to the end of the transition period.
Countdown to EU IVDR
In Vitro Diagnostic manufacturers in the European marketplace need to develop and implement strategies in order to be fully compliant. They will otherwise face resource challenges if preparation is left to the end of the transition period.
Date of application to the EU IVDR
26th May 2022
IVD Services
Gap Assessments
- Device Classification as per IVDR (Classes A, B, C, D)
- IVDR Readiness Audits and Mock Audits
- Technical Documentation
- QMS development and implementation
Global Registrations
- UDI and Labeling Requirements
- Technical File Creation
- Submission and Review
- CE-Marking and International
Medical Writing
- Performance Evaluation Plan (PEP)
- Performance Evaluation Report (PER)
- Scientific Validity Report (SVR)
- Analytical Performance Report (APR)
- Clinical Performance Report (CPR)
- Post-Market Performance Follow-Up Plan (PMPF)
Areas of IVD our team has experience in:
Companion Diagnostics
- Lab Developed Tests (LDTS)
- Point of Care Tests (POC)
- Instrumentation Lab Management Systems
- Molecular Diagnostics
Why choose Celegence as your IVD regulatory partner?
Celegence is entrusted by 3 of the Top 10 leading Life Science companies to support their regulatory initiatives and provide strategic guidance. We have expertise and know-how to navigate the complex regulations on a global scale, supporting all stages and risk classifications.
Our size allows us greater flexibility in working to accommodate our clients as quickly as possible in order to meet impending deadlines. We work as an extension of your regulatory team, filling in gaps as needed, or providing the full suite of support by completing the entire scope of work required for market approval.
Contact Us
Let us help you navigate the EU IVDR regulations and gain market approval.
Contact us today to learn more.