Content by Jon Speer
FDA Form 483 Observations and Warning Letters: What’s the Difference?What you should know and what you should do
Wed, 03/11/2020 - 12:03
If you’re a medical device company manufacturing Class II or Class III devices, you can expect to have the U.S. Food and Drug Administration (FDA) turning up for an inspection. It’s what happens after that inspection that we’re concerned with in…
Paper Is ExpensiveThree ways a paper-based quality management system can cost your company big time
Mon, 02/17/2020 - 12:02
Believe it or not, paper is very expensive. Although the going rate for a ream of standard copy paper is only about 10 bucks, the expense of relying on paper for your medical device quality management system is downright outrageous. Some medical…
Five Tips From Medtech Executives on the Value of QualityWe all benefit from a larger perspective
Tue, 10/22/2019 - 12:02
When it comes to making medical devices, quality is key. That’s a concept that nearly every medical device professional agrees with, but what does it mean? Why is quality so important, and how should it be pursued? These are the questions that…
Implementing ISO 13485Six common mistakes and how to avoid them
Tue, 09/10/2019 - 12:03
Medical device manufacturers must implement and maintain a quality management system to ensure they are producing safe and effective medical devices. Created and maintained by the International Organization for Standardization (ISO), standard 13485…
Qualifying Your Suppliers Using a Risk-Based ApproachLessons from the medical device industry
Thu, 06/13/2019 - 12:02
This notion of risk-based processes within quality systems is something that has become part of our formal lexicon following the release of ISO 13485:2016, the globally harmonized standard for medical device quality management systems (QMS). Well…
Eight Things You Need to Know About the European Medical Device RegulationSetting up for long-term success
Tue, 06/04/2019 - 12:02
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their…
What to Expect During an FDA QSIT InspectionAs a medical device manufacturer, you can expect to be inspected
Tue, 03/19/2019 - 12:03
You arrive at work one morning, and there are FDA inspectors sitting in your waiting area. If you are lucky, you may be notified ahead of time that they’re coming, but otherwise, the US. Food and Drug Administration (FDA) is fully within its rights…
Five Common Mistakes Companies Make With CAPAAvoid jeopardizing the health of your QMS
Wed, 06/20/2018 - 12:03
We raise the corrective and preventive action (CAPA) topic often because it is still something that companies tend to struggle with and find themselves in hot water over, particularly when it comes to regulatory audits or inspections. There’s often…
Why the FDA Presubmission Is an Underutilized ToolWhat you don’t know can definitely hurt you
Mon, 04/30/2018 - 12:03
“I wish there was a way for the FDA to give me a heads-up about my stuff, prior to submission….” That sentiment was really the basis behind the U.S. Food and Drug Administration’s (FDA) presubmission tool, as I was discussing recently with medical-…
How to Integrate Complaint Handling and Risk ManagementLet technology help
Tue, 01/30/2018 - 12:02
Complaint handling continues to be one of the biggest reasons medical device companies receive 438s and warning letters from the U.S. Food and Drug Administration (FDA). Companies have a lot going on once a medical device has reached the market,…