Organizations in the Medical Devices and Diagnostics industry face a serious challenge – deliver safe, profitable products on-time, every time. New regulations with tight deadlines such as those for EU’s MDR and IVDR are pushing companies to meet these new requirements to ensure their products continue to remain on the market. But it doesn’t stop there:
- migrating to ISO 13485:2016
- reducing audit costs by participating in MDSAP
- struggling with 510(k) class exemptions
- preparing for UL 2900 cybersecurity requirements adoption by the FDA
- push to change to the use of electronic records and signatures in Medical Devices clinical investigations
Companies can no longer face a compliance “status quo” with all these changes in the market and regulations. More emphasis is being put on risk (as seen in ISO 13485”2-16, ISO 9001:2015, etc.). But in this case the risk discipline is evolving and being looked at as a tool to create value and achieve higher levels of performance. It’s no longer something to only fear, minimize and avoid. Medical Devices companies will need to change their risk approach from the beginning of the design cycle and throughout the product value chain.