Celegence has 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. We have the wealth of knowledge to help you navigate through the complex challenges that IVD Regulation inherently brings.
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Webinar Background
This webinar will provide practical steps to overcome common challenges in IVDR compliance, looking forward to it.
This Webinar Will Cover:
1. Clinical performance studies for IVDs:
- Applicable ISO standards to be complied with
- Differences with the MDR requirements
- Guidance’s providing useful information
2. Post-market requirements & ensuring PMS is gathered compliantly
3. How much evidence is enough for IVDs products
4. Literature evidence for IVDs:
- Areas to consider while executing the searches
- Best practices for analyzing & appraising the data
- Validating the search protocol
This featured presentation will be led by Celegence’s Medical Device/IVD RA Expert, Smridula Hariharan.
Our medical device and IVD expertise also includes region specific support for submissions, and global regulatory consulting and intelligence. If your team has not begun addressing any of these areas above, reach out today for a Celegence IVDR Gap Analysis that will comprehensively examine all relevant aspects of your regulatory process. Reach out to us at info@celegence.com!