EUMDR
EUMDR
As we know, the new EU MDR regulations in 2017 came with a complex set of rules with strict vigilance and high standards which aims to provide safe and quality medical devices rendered to the healthcare society to ensure people’s safety. Therefore, compliance with EUMDR regulations is mandatory for medical device companies to get approved for “CE” marking on their products, which allows them to sell their product in the European marketplace.
Our organization is well seasoned in providing the best of consultants that can ensure regulatory compliance of the product they work on. Here at Career Prime, our consultants provide support to a wide range of medical device clients in getting their products released in the market with full compliance regarding new EU MDR regulations in the European marketplace.
At Career Prime, consultants have expertise in following but not limited to:
- Perform Gap analysis and DHF remediation
- Meeting General Safety Performance Requirements
- Reclassification of devices according to risk, contact duration, and invasiveness
- Complying with Quality Management System and Risk Management System
- Meet Regulatory compliance and support Technical Documentation
- Clinical Evaluation Plan/Reports and Post Market Surveillance, PSUR’s
- Post Market Clinical Follow Up (PMCF) and SSCP
- Work with notified bodies for Declaration of Conformity
- UDI Implementation: Unique Device Identification for better traceability and recall
“Your trust – Our Quality”
At Career Prime, we understand the needs of clients, thus we strive to supply the best of the consultants to clients as per their skillsets and experience.
177 Center Point Rd,
Suite 104, Weatherford
Texas 76087
+1 656 2074158
hr@careerprimesolutions.com
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