We specialize in developing the most critical part of the technical documentation – the Clinical Evaluation – in line with the latest regulatory requirements and the expectations of Notified Bodies under MDR 2017/745.
What can we do for you?
1. Prepare a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) fully compliant with MDR
2. Update your existing documentation to meet MDR requirements
3. Create a well-structured literature search protocol and assess the resulting data
4. Conduct periodic reviews of your Clinical Evaluation
5. Deliver a Preclinical Report for your new medical device
6. Advise you on updating your technical documentation
We draw on hands-on experience across a wide range of projects and medical device classes. We understand which aspects tend to raise questions from Notified Bodies – and we use that insight to build documentation that’s thorough, focused, and helps you avoid time-consuming revisions.
Company Details
- Employees
- 1
- Founded
- -
- Address
- Gliwice, Pl
- Industry
- Business Consulting And Services
- NAICS
-
Management, Scientific, and Technical Consulting ServicesManagement Consulting ServicesOther Scientific and Technical Consulting ServicesOther Management Consulting Services
- Website
- http://cerdev.pl
- Keywords
- medical devices, regulatory affairs, MDR, Clinical Evaluation, Clinical Evaluation Report, Clinical Evaluation Plan, CER, CEP.
- HQ
- Gliwice
Cerdev - Mdr Clinical Evaluations Questions
Cerdev - Mdr Clinical Evaluations's website is http://cerdev.pl
Cerdev - Mdr Clinical Evaluations's LinkedIn profile is https://pl.linkedin.com/company/cerdev-clinical-evaluation
Cerdev - Mdr Clinical Evaluations has
1 employees.
View email and phone details for 1
employees at Cerdev - Mdr Clinical Evaluations.
Cerdev - Mdr Clinical Evaluations's industry is
Business Consulting and Services
Cerdev - Mdr Clinical Evaluations's top competitors are
Deltaprime,
Devgomed,
European Healthtech Innovation Center - Ehtic,
Webgirondins,
Mróz Radcy Prawni Sp. P. - Kancelaria Branży Budowlanej,
Mdr Regulator,
Messer Polska,
Clinical Evaluation Navigator,
Good Medica Sp. Z O.o.,
Arrotek Medical Ltd.
Cerdev - Mdr Clinical Evaluations's categories are Business Consulting and Services
Cerdev - Mdr Clinical Evaluations's founding year is 2024
