2016 has brought its share of changes and announcements in the applicable regulations and standards. Many actors have already started to perform Gap analysis, build plan, and update their Quality Management System to implement or anticipate these changes.
For our last newsletter of the year, we compiled a summary of those changes, recent and upcoming.
ISO 13485:2016 + Training
Whether you are new to the standard or transitioning from the 2003 or: 2012 version, entrust our training organization to ensure a smooth transition... Read more.
The MDSAP program is reaching the end of its pilot phase at the end of December 2016 and enters its implementation phase... Read more.
MEDDEV 2.7.1 Rev 4
The New MDR and IVDR
The new revision 4 of 2.7.1 MEDDEV does not fully change the Clinical Evaluation process but includes much more detailed information... Read more.
In June 2015, a new draft of both the Medical Device Regulation and the In Vitro Diagnostic Regulation was published... Read more.