FDA QMSR: Why You’re Already Behind The FDA’s new Quality Management System Regulation (QMSR) will soon be in effect, and the countdown to compliance is already underway. By February 2, 2026, all medical device manufacturers must meet the updated requirements of 21 CFR Part 820, which now aligns closely with ISO 13485:2016. While the deadline ...
ISO 9001 Revision 2026, IA9100, ISO 14001 - Who, What, When, Why, and How? The new ISO standards are coming, and we all know it. But just because you know something is coming, doesn't mean you have all of the answers you need. The truth is, we don't have all of the answers either, but many of the questions on your mind have answers. In this webina...
[formidable id="8" title="1" description="1"] FDA Risk Requirements for Your QMS Now & What’s Coming in 2025, QMSR & Beyond Enjoy our discussion on what the current risk requirements are for the FDA and what risk requirements need to be implemented. This free webinar addressed many of the FDA risk requirements for the following indus...
[formidable id="4" title="1" description="1"] The Top 5 FDA Violations & How to Prevent Them Watch our discussion on how to react to FDA violations and how to prevent them from the beginning. This free webinar addresses the top violations cited by FDA Inspectors in the following industries: Medical device Pharma / Drug / OTC...
[formidable id="6" title="1" description="1"] The Monumental Power of MDSAP Certification Worried about the FDA knocking on your door? Wish you could protect your company from unwarranted inspections? Did you know the FDA has endorsed: • ISO 13485:2016 as the basis of the QMSR? • MDSAP certification? Did you also know MDSAP ce...
[formidable id="1" title="1" description="1"] 3 Critical Mistakes Made During Root Cause Investigations Ask yourself: How many nonconformities or customer complaints keep reoccurring? How many of your root cause investigations only dealt with the problem’s symptoms? If your answer is higher than 1 or 2, then your company is pro...
[formidable id="3" title="1" description="1"] 5(+1) Most Important Auditing Mistakes Most Internal Auditors Make Does the thought of conducting an internal audit make you sweat? You’re not alone. Auditing should be a positive and productive experience for all involved. But due to inexperience and lack of training, internal auditors frequentl...
[formidable id="7" title="1" description="1"] Transitioning from MDD to MDR – 3 Pitfalls to Avoid Do you know what pitfalls most medical device manufacturers are experiencing as they RUSH to get their devices approved and transition from MDD to MDR? Using old documents and records thinking they will be approved. Getting Nonconform...
[formidable id="6" title="1" description="1"] Failures of the 3 Core Quality System Processes To have an effective and value-additive Quality System, it MUST have these 3 quality system processes working seamlessly: Problem Identification Process Problem Resolution Process Management Review But what if they don't? In this w...
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