Full design controls for global 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 MDR and FDA 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 and that it can bog a project down. We ensure our process and outputs for regulatory submission are highly efficient by using Aligned Elements as our traceability software.
Our services include risk management to ISO 14971: 2019 through using FMEA’s, Fault Tree Analysis etc., and can provide 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.