What We Do?

CDAQI research provide a Comprehensive and End to End Clinical Trail Management Services for Medical Devices Industry, which includes Clinical Research strategy, Clinical Trial Management and Post market clinical follow-up services.
The PMCF (Post-Market Clinical Follow-up) is performed after a medical device has been placed on the market. The goal of the PMCF is to update the clinical evaluation report with new data on patient safety and device performance following the CE marking of the device.
Clinical Evaluation Reports are required for all medical devices in Europe. You must submit your CER to your Notified Body as an attachment to your European CE Technical File.
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The new EU MDR goes into effect on May 26, 2021: at this date, the recent PMS, vigilance, and market surveillance requirements will apply, and manufacturers must submit device certification applications. New requirements include increased clinical data requirements for manufacturers, which entail more rigorous planning for companies intending to certify or gain re-certification under the new regulation.
Regulators require PMCF with PMS and clinical evaluation reporting (CER) obligations and risk assessments and reassessments.
The EU MDR includes PMCF studies previously addressed under MEDDEV 2.12-2 guidance and reinforces the need to conduct PMCF.
Manufacturers should develop PMCF plans, including all PMCF activities for the expected lifecycle of their devices. Article XIV Part B section 6.2 of the EU MDR details the specific components manufacturers should include in their PMCF plan.


- PMCF Studies (or observational or non-interventional clinical investigations)
- Post-Market Interventional Clinical Investigations
- Evaluation of data from suitable registries
- Investigator initiated studies
- Case cohorts
- Other subject-specific clinical data collection activites