EUROPEAN MEDICAL DEVICE REGULATION

EUROPEAN MEDICAL DEVICE REGULATION

SERVICE OVERVIEW

EUROPEAN MEDICAL DEVICE REGULATION

EU MDR COMPLIANCE CONSULTING

Empirical Technologies Corp. can ensure that you are fully prepared and compliant with the new EU MDR regulations.

Our EU MDR consultants at Empirical Technologies Corp. are knowledgeable about how the new EU MDR regulations will affect the current European medical device consulting processes and requirements. From building a clear timeline to carrying out a strategic gap analysis to delivering EU MDR training for continual improvement, we assure your implementation process will reach the deadline with the specialties essential to accurately advise the transition.

Our team will guide you through the EU MDR process every step of the way to ensure that your company transitions efficiently and successfully.

 

WE ARE HERE TO ASSIST YOU

The landmark EU Medical Device Regulation (EU MDR) became fully operational on May 26, 2021 and replaced the Medical Device Directive (MDD) of 1993. New medical device standards were adopted by EU MDR consultants for the purpose of ensuring patient safety and improving adverse event reporting. This new legislation also lengthened the time to market and required revisions to existing quality management systems, clinical trial and data standards, post-market surveillance requirements, and more, making life considerably more interesting for regulatory affairs teams around the world.

Empirical Technologies Corp. has years of experience as an EU MDR consulting firm establishing effective and successful regulatory plans and expertise to decipher complex regulatory requirements so you can be able to comply. Whether your transition demands a comprehensive redesign of your quality management system, a full technical file, and design dossier, or simply some mock EU MDR audit assistance, our European medical device consultants have the expertise and experience to guarantee that your transition will be efficient and successful.

A clear and well-defined strategy, collaboration with a notified body, compliance with new regulations, and lots of documentation are required in order for you to achieve your EU MDR certification. There is so much documentation that even the most dedicated and focused EU MDR consultants can miss a clinical detail or a page number. This is the reason why Empirical Technologies Corp. provides independent quality control reviews and inspections of your EU MDR application to make sure that there are no administrative, clinical, or technical flaws that could jeopardize your certification. We can also assist you in drafting a compliant response outlining the designed mitigation if your notified body does issue a notice of non-conformities.

Empirical Technologies Corp. understands and is aware of how the new European medical device consulting regulations will affect the current medical device processes and requirements, and our company is here to assist you in navigating the transition. So that you can focus on improving your business, our EU MDR consultants will work with you to make sure that your procedures, systems, and documentation are completely compliant. Contact us today for all of your EU MDR Compliance Consulting needs!