iso 13485:2016 Posts

ISO 13485:2016 Compliance: Yes, It’s That Urgent

ISO 13485:2016 Compliance: Yes, It’s That Urgent

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions

We’ve been talking about getting ready to meet the ISO 13485:2016 deadline for a while now, urging organizations to perform regulatory gap assessments, get a compliance update plan in place, and execute. In fact, I just reminded everyone again a few days ago in my blog about the steps to take to get compliant prior to March 1, 2019. So do we really need to address it again? Well, yes, because it is that urgent!

Timing Urgency

If your organization is currently certified to the ISO 13485:2003 standard, then it is important for you to know that before March 1, 2019, re-certification to ISO 13485:2016 will be required for your organization. You’re probably thinking that’s over a year away, we’ve got time! But consider this — from personal knowledge I can tell you that you are definitely not alone in the need to get this done within the next 12 months, and the queue for ISO 13485:2016 certification is long! Therefore, if you’re not done yet, or you haven’t even started, get some help to expedite the process.
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ISO 13485:2016 – The Countdown is On!

ISO 13485:2016 – The Countdown is On!

Kari Miller, Regulatory and Product Management Leader, Pilgrim Quality Solutions

How much effort will it take to get your organization ready for ISO 13485:2016? The February 28, 2019 deadline is now just one year away, and many organizations need to take advantage of every minute between now and then to be compliance-ready. Busy registrar schedules, combined with your company’s certificate expiration, mean that you may have less time to prepare than you think.

Medical device manufacturers that aren’t prepared for the change will need to do some heavy lifting with regard to quality management practices and processes to stay compliant with the updated standards. Do you know the level of effort needed by your organization to get ready for the new version of ISO 13485? Here is some insight on where to start.
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ISO 13485:2016 Audit Readiness: Your Questions Answered

ISO 13485:2016 Audit Readiness: Your Questions Answered

Kari Miller, Regulatory & Product Management Leader, Pilgrim Quality Solutions
Cynthia Lambert, Regulatory Specialist, Pilgrim Quality Solutions

Last week, Pilgrim hosted a webinar titled “The Ultimate Guide to ISO 13485:2016 Assessment Readiness.” During the session, we presented comprehensive tips, best practices, and solutions to ensure that your team is prepared and confident when the assessor arrives. If you weren’t able to attend the live webinar, you can access the on-demand version here.

ISO 13485:2016 is a critical topic for medical device manufacturers, and we were delighted to address many questions on assessment readiness at the end of the presentation. Here are 5 interesting questions (with answers) from the webinar’s Q&A session that will help you better prepare for your assessment.
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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.
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EU Medical Device Regulations: Changes on the Horizon

EU Medical Device Regulations: Changes on the Horizon

Cynthia Lambert, Regulatory and Industry Specialist, Pilgrim Quality Solutions

There are significant changes on the regulatory horizon in Europe due to the publication of the new European Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), which were approved by the European Parliament on April 5, 2017. The industry is now subject to a three-year transition period for compliance among medical devices, and a five-year period for compliance among in vitro diagnostic (IVD) products.
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Key Takeaways: Choosing the Right QMS for ISO 13485:2016 Compliance

Key Takeaways: Choosing the Right QMS for ISO 13485:2016 Compliance

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

Last week, we hosted a webinar titled “Choosing the Right Quality Management Solution (QMS) for ISO 13485:2016 Compliance.” During the presentation, we provided a brief overview of changes to the updated regulation, details on certification timing, and a demonstration of how Pilgrim’s SmartSolve® quality management software simplifies compliance with the new version of the standard. If you missed the live session, you can view the on-demand version of our ISO 13485:2016 solution webinar here.
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ISO 13485:2016 and Supplier Management – A Reflection of the World Around Us

ISO 13485:2016 and Supplier Management – A Reflection of the World Around Us

Kari Miller, Vice President of Regulatory and Product Management, Pilgrim Quality Solutions

The global economy is often the topic of blogs, articles, and macroeconomic discussions. It’s no surprise that it’s become a leading consideration in the field of Quality as well. The global economy has added complexity to our supply chains making it more important than ever to assess and control supplier risk. Lengthy supply chains make it more difficult than ever to manage suppliers and remain compliant with the plethora of regulatory requirements around the world. The updates to ISO 13485:2016 reflect this reality.
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Global Harmonization and the Link between ISO 13485:2016 and MDSAP

Global Harmonization and the Link between ISO 13485:2016 and MDSAP

Kari Miller, Vice President of Regulatory & Product Management, Pilgrim Quality Solutions

Let’s face it. The world of trade is shrinking. It’s no longer enough to design, build, and distribute a product in compliance with the manufacturer’s national regulations. Within each phase of product development, the manufacturer must abide by global regulations as well. If you’re a medical device manufacturer, and you haven’t started looking at ISO 13485:2016 and the Medical Device Single Audit Program (MDSAP), you’re running out of time!
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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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