We can guide you through the regulatory maze to ensure that your product meets regional regulatory approvals. We help clients with products that have failed EMC or where radio approvals have been overlooked.
Developing medical devices to adhere to highly regulated international approvals processes is complex. We are experienced at developing electronics and software using processes that adhere to these strict medical device regulations.
In the EU Regulation (EU) 2017/745 on Medical Devices applies on the 26th May 2021 and replaces the MDD. A handy transition timeline is available - MDR transition timelines. One of the main drives of the MDR is ‘post-market surveillance’ which seeks to address the ongoing safety of a medical device taking the full lifecycle in to consideration. This means that medical devices must now be compliant with present and future regulations.
Prior to developing medical devices, we worked in the design and verification of aerospace components and systems. Consequently, we have extensive experience in design for safety critical and mission critical systems.
We have extensive experience of designing and verifying fault tolerant systems, circuits, software, and firmware and mitigating single event upsets. We have been responsible for identifying and fixing design defects and documentation errors and omissions in high profile aerospace projects.
Our client was concerned with the progress and quality of the verification and associated documentation for a major component in a new helicopter design that had been outsourced. We were brought in to control and oversee the program. Verification was analysed, corrected and the project was put back on track – the client was happy and helicopter was successfully flown.