By: Hugo Felix, Director Design Quality Assurance, Bard Access Systems
This is Your Wake Up Call!
The Medical Device and Diagnostics Industry is experiencing rapid regulatory changes. To deal with these changes there are certain key areas that need to be addressed so we can thrive, rather than just survive. Quality Systems need to account for that, deal with the rapid pace and help us manage it.
New standards, regulations and guidances will have a significant impact in our industry:
- The International Organization for Standardization (ISO) published ISO 13485:2016. This represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices
- ISO 13485:2016 has a 3 year transition period and no new accreditations to the 2003 version after year 2
- TC210 just approved changes to ISO 14971, Application of Risk Management to Medical Devices and an update to the accompanying ISO TR 24971 and a new TR for Post Market Surveillance
For its part, the US FDA issued guidances late last year on Benefit Risk Analysis for Pre and Post Market and draft guidances for deciding when to submit a 510K for device changes and another for software changes. MDD/IVDD to MDR/IVDR change is slated for May 2017 with full implementation deadlines of 2020 for MDR and 2022 for IVDR.