Medical device regulatory services
GAP analysis for correct compliance
We offer you our three step approach for compliance:
- Our experts for regulatory and quality management will review available technical documentation
- You will receive the gap report highlighting the state of compliance with the requirements of MDR and/or ISO 13485
-Mutually agreed gap report drives and proposal for maximizing strengths and optimizing possible modifications and revisions.
Building up regulatory strategy
HungaroTrial places regulatory consultancy in the context of the Life Cycle of Medical Devices, be it for alignment with strategic business goals or for implementation of specific regulatory plans. We propose directions to support Clients to navigate along the diverse and scrutinized regulatory pathway with understanding specific needs of our clients and uniqueness of their products. We are aware that keeping an already lounched product to the market under continuously changing regulatory environment is challanging, so we are here to support this, and make sure that everything is under control.
Technical Documentation compliance
Maintenance of adequate Technical Documentation is critical element on the conformity assessment pathway. The synergy of HungaroTrial scientific and technical expertise, competency in medical device trials and regulatory intelligence results in our ability to manage Biocompatibility and Safety tests, Clinical evaluations, Post Market Clinical Follow-up, Post Market Surveillance and Risk Management to ensure Technical Documentation is remaining suitable for declaring conformity.