Full design controls for MHRA & FDA regulatory compliance
During device development for volume manufacture, full Design Controls are applied within our formal device development process. This ensures projects are properly managed and provide evidence for MHRA and FDA Regulatory Compliance. Many consultancies want pure design and development work only, they aren’t interested in supporting you with the administrative side of developing a new medical device. However at HD, we understand the burden of compliance can sometimes bog down projects, so are happy to help with all the aspects of the device development process. Our services include risk management to ISO 14971: 2012 through FMEA’s, Fault Tree Analysis etc., and the support required to ensure full project compliance with regulatory requirements.
If you are encountering difficulties, need expertise, resource or have a problem to solve then please give us a call, we will always try to help.