Medical device product developers and manufacturers are constantly under scrutiny by regulatory organizations. Standards and regulatory bodies like the FDA, ISO and IEC may seem draconian in their approach, but is critical that they apply highest and strictest standards when it comes to life-saving products.

7 things you can do:

1. Review processes: Sounds fairly basic, but there needs to be a single process that drives all product activity.
2. Audit procedures: Perhaps establishing isn't quite enough, but is the starting point. It is regularly noted that there is a direct correlation between time of detection of quality issues and the speed at which a product will pass regulatory scrutiny and be brought to market
3. Feedback loops: A QMS can help to establish and adhere to a regular loop of feedback among stakeholders and decision-makers, which allows for fact action an quick addressing of problems that might otherwise impede product development.
4. Content management: Standards bodies and regulatory agencies will want to review everything related to product development. Using a QMS enables all documentation to be stored, tagged, and be resources as necessary to make continuous development easier
5. Corrective action: CAPAs are meant to alleviate poorly designed processes and rectify issues before the completely derail projects. A QMS is critical this regard because it helps establish levels of quality that must be met, and triggers can be applied when they are not.
6. Training management: Training is a critical piece of the medical device product process, and a QMS helps ensure the all processes are standardized and that reasons for them being addressed are made apparent.
7. Reporting and submission: A QMS maintains continuous record of all actions around the medical device product development, and when communication with the FDA or ISO is required, it can help to pull all necessary data and deliver for review.

SIGNIFICANT CHANGES AHEAD FOR MEDICAL DEVICE MANUFACTURERS

Medical device manufacturers will soon be confronted with major changes in the EU’s decades-old regulatory framework which governs market access to the European Union (EU). The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC).

The Medical Device Regulation was officially published on May 5th 2017 and came into force on May 25th 2017. Manufacturers of currently approved medical devices will have a transition time of three years until May 26th 2020 to meet the requirements of the regulation. For some manufacturers the new regulation provides an additional time after the date of application allowing them to place new products for max. 4 more years on the market. Additional requirements will apply for this extended transition period. The corrigenda for the MDR and IVDR have also been made public.