HEMBRY Consulting offers simple, low-cost solutions regardless of whether you are introducing a new medical device or looking for assistance in assuring compliance for existing devices in your product portfolio. Our FDA consultants can assist with UDI compliance.
A well-established, formal, Design Control process will ensure that the DHF and Tech-Files contain all of the records required. As the medical device regulatory requirements change and as you update your Quality System, it is important to ensure that Design History Files and Tech-Files for legacy products are compliant to the new standards.
The new regulations seek to increase medical device safety and effectiveness in the EU Market while addressing weaknesses revealed in the implementation of the Medical Device Directive. As part of our Consulting Services for Medical Device and Combination Products, Hembry Consulting MDR Implementation can support your products transition to the new regulations.
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