The ISO 13485:2016 standard is new and needs to be looked at afresh

With the ISO making the final version of the ISO 13485:2016 standard available; it is now up to companies to start planning ways of implementing it. The major area in which it differs from the earlier version (of 2003) is in the extent of its alignment with the FDA’s Quality Management System (QMS) requirement. Although this version shows a higher level of this aspect; there still exist points of deviation from the FDA’s QMS, making this the area that companies that need to comply with this standard need to focus on.

In order to help such companies understand the ways of grasping the 2016 ISO 13485 standard better and to offer them insights into it; GlobalCompliancePanel, a highly reputable provider of professional trainings for the regulatory compliance area, is organizing a seminar.


A learning session to help professionals understand the ISO 13485:2016 better

This seminar will offer clarity on how to implement the new ISO 13485:2016 standard. This seminar assumes significance in the light of the fact that not only is the new regulation quite complex; for many companies, the implementation period is quite short, depending on the expiry date of their current certificate.

More details of the seminar can be had from

The Director of this seminar, Dan O’Leary, who has experience of over 30 years in various quality, operations, and program management in regulated industries, will offer practical implementation advice and suggestions to participants. He will explain the points at which there is both convergence and divergence between this revised standard and the FDA’s QSR requirements. He will also show that the regulatory systems in a few jurisdictions will continue to depend on ISO 13485:2016 through the Medical Device Single Audit Program (MDSAP).

Areas of concurrence and departure

Dan will describe the areas in which the US and the EU differ in this regard. It is in these: The US will participate in MDSAP, but will not expect to change its regulations. On the other hand, the EU is not going to participate. It will implement its own published version, the EN ISO 13485:2016, and will continue with the existing Notified Body system. However, the EU will implement its own set of new regulations that will replace the directives. These will lead to new regulations that will be newer versions of EN ISO 13485:2016 and EN ISO 14971:2012.

In the course of this explanation, Dan will make use of exercises and examples with which participants will understand the ways of implementing according to the new guidelines. He will also use these to help them analyze the consequences of the newly revised regulation in a few regulatory systems including MDASP and its nonconformity grading system.