The Path to ISO 13485:2016 Compliance – Are You Audit Ready?

The Path to ISO 13485:2016 Compliance – Are You Audit Ready?

Sandy Carson, Marketing Manager, Pilgrim Quality Solutions

The industry continues to be buzzing about ISO 13485:2016, and with good reason. The March 1, 2019 deadline is inching ever closer and some organizations are in full preparedness mode. Some have already even conducted mock audits. Others have been granted new product approvals with the new ISO criteria already coming into focus for them. Others are simply putting team plans in place for their implementation and/or upgrade to ISO 13485:2016-ready Quality Management Software (QMS) solutions.

Since April of this year, Pilgrim Quality Solutions, through a 4-part webinar series and additional published subject matter expert content, has been providing Life Science organizations with a path to the new ISO 13485 changes and requirements. Pilgrim has a handle on all of the upcoming changes, and wants to see organizations through them so they remain fully compliant and don’t miss a step along the way.

We will present the final webinar in our ISO 13485:2016 transition webinar series, The Ultimate Guide to ISO 13485:2016 Audit Readiness, on October 11 at 11:00 am. In this webinar, we’ll provide guidance on how to prepare Quality leaders, their team, and their Quality System for a successful ISO 13485:2016 audit. Attendees will get a good handle on how to train their team, proper auditee etiquette, and the Quality system data they should have on hand to be audit-ready.

Medical device companies gearing up for the new ISO requirements should also consider the impact of the upcoming eMDR changes on the horizon. This past February, the FDA announced Electronic Submissions Gateway (ESG) ACK 3 schema changes that will affect medical device reporting beginning in June 2018. The time for submitters to prepare for the updated schema is now to allow ample time to develop and test against the new schema.

Manufacturers are advised to take stock — in addition to being Audit Ready, are you Reporting Ready, too?  Pilgrim Quality Solutions and its QMS Management 3.0 solutions will have its customers ready for both the eMDR changes, as well as ISO 13485:2016 requirements.


Sandy Carson

Marketing Communications & Events Manager, Pilgrim Quality Solutions

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