Monthly Archives: August 2017

The Notified Bodies are already very busy and our medical device manufacturing clients are already seeing increased audit times. Several European Notified Bodies are no longer taking new clients with the onset of MDSAP (inclusive of ISO13485:2016), MEDDEV 2.7.1 Rev. 4 & MDR. This is the beginning of a 3-year debacle for medical device companies. These substantial regulatory reforms are now underway and will be required over the next 3-5 years: MDSAP will become the mandatory replacement for the CMDCAS certification to support Canadian device approvals on January 1, 2019…
Read More »