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Medical Device Product Risk Management

Presented by John Lincoln, EAS Independent Consultant

February 28, 2022 at 1pm eastern

Both the U.S. FDA and the EU’s MDR require product risk management as part of virtually all regulatory compliance efforts. Companies must be proactive in reducing product risk while increasing user benefits though many are still not developing the required tools nor using them in all regulated / CGMP activities. And though when they are used, companies are not providing the documentation to allay investigators’ / auditors’ concerns, meaning existing risk documents are not used to their full potential.

ISO 14971 (and ICH Q9) provide excellent starting points for developing a Product Risk Management Program and Files. This EAS webinar will provide valuable assistance to all regulated companies that need a repeatable methodology, and their in-house personnel trained in cGMP and MDR/CE-marking compliance. It will discuss and provide examples of ISO- and FDA/ICH-compliant product risk management templates, ISO 14971 and CGMP 21 CFR 820 (and ICH Q9 and 21 CFR 210/211) applying to companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields.

EAS Offers Client Discount on Medical Device Risk Assessment and 510(k) Preparation

A third-party review of your device risk assessment will enhance your product’s safety as well as reduce your regulatory risk. How granular is your risk assessment? What quality provisions are in place for supplier agreements? How will you execute a recall? Is the level of detail sufficient to support a 510(k) submission?

Registrants of our Medical Device Risk Assessment webinar can receive 5.10% off an expert device risk assessment review and 510(k) submission by signing an EAS client agreement* on or before February 28, 2022.

Work directly with our expert consultants for a detailed look at your cGMP compliance per 21 CFR 820. Identify strengths and enhance weaknesses and be ready for your next FDA inspection.



Email Bryan Coleman, EAS Senior Director for Pharmaceuticals and Medical Devices to discuss the benefits of becoming an EAS client, including receiving a 10% discount on your next device risk assessment and 510(k).

* Offer is available for new clients of EAS only.

About the Presenter

John Lincoln

EAS Independent Consultant, John Lincoln, has worked with companies from start-ups to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. John has held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, he has prior experience in military, government, electronics, and aerospace. John has published numerous articles in peer reviewed journals, book chapters, conducted workshops and webinars worldwide. He is a graduate of UCLA.

Posted in Medical Devices, Webinar.