ISO 13485 Posts

Risk Management: Key Takeaways from Last Week’s ISO 13485:2016 Webinar

Risk Management: Key Takeaways from Last Week’s ISO 13485:2016 Webinar

Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions

Last week we hosted a webinar titled “Regulations, Risk, and Responsibilities: Closing the Gap on ISO 13485:2016 Compliance.” The webinar was presented by Dan O’Leary, President of OMBU Enterprises, and Kari Miller, Pilgrim’s Vice President of Regulatory and Product Management. If you were unable to attend the webinar, you can watch the Closing the Gaps in ISO 13485:2016 Compliance On-demand Webinar.

During the webinar, Dan presented several areas where the latest version of ISO 13485 will present significant challenges to medical device manufacturers. These areas include supplier management, complaint handling, integrating regulatory requirements into the quality system, and the way your company approaches risk.
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ISO 13485:2016 Compliance: Resources to Help You Get Started

ISO 13485:2016 Compliance: Resources to Help You Get Started

Roxane Napoli, Marketing Manager, Pilgrim Quality Solutions

Transitioning to ISO 13485:2016 compliance is the top priority throughout the medical device industry right now. The industry is racing to absorb information on the latest version of the standard. Do you have a plan in place for getting your organization up-and-running with ISO 13485:2016? These resources will help you develop, fine tune, and implement your transition plan.
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The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

The Path to ISO 13485:2016 Compliance – What’s Your Next Step?

Justin L. Smith, Manager of Product Management, Pilgrim Quality Solutions

This industry continues to buzz about ISO 13485:2016. The February 28, 2019 deadline is now less than two years away, and many organizations need to take advantage of every minute between now and then to be compliance-ready. Plus, busy registrar schedules, combined with your company’s certificate expiration, mean that you may have less time to prepare than you think.

Pilgrim is here to help you along the path to compliance. Are you ready to move forward?
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Pilot Program for ISO 13485 Audits Sounds Promising

Mark Crawford

On March 19, the FDA announced guidance for a medical device ISO 13485:2003 voluntary audit report submission program. The document provides a strategy for responding to Section 228 of the Food and Drug Administration Amendments Act of 2007, which states that:

“For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality system standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.” (more…)