Content by Jon Speer

Jon Speer's picture
Jon Speer
“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...
Jon Speer's picture
Jon Speer
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...
Jon Speer's picture
Jon Speer
Corrective and preventive action (CAPA) is an important process for your medical device company. In fact, the U.S. Food and Drug Administration (FDA) states in its Quality System Inspection...
Jon Speer's picture
Jon Speer
What exactly is a risk-based quality management system (QMS)? This is a timely topic to get into. In 2016, ISO 13485—“Medical devices”—“Quality management systems” was updated, and one of the key...
Jon Speer's picture
Jon Speer
How confident are you when it comes to design validation? Does this always involve clinical evaluation, or not? We’ve found that, like many other terms in medical device development, the two...
Jon Speer's picture
Jon Speer
Medical device startups tend to share many common issues. They are usually striving for better resources (such as people and capital) as well as the knowledge and expertise required to deal with...
Jon Speer's picture
Jon Speer
If you’re in the medical device industry, you may think that design controls are a confusing imposition on your processes. But they’re a necessary part of your requirements as a medical device...
Jon Speer's picture
Jon Speer
If you’re in the business of developing medical devices, then risk and risk management become terms synonymous with your daily operations. Your overall task is to bring a device to market that not...
Jon Speer's picture
Jon Speer
Did you know that during the first six months of 2015, 69 percent of 510(k) submissions were rejected the first time? And that up to 75 percent of first-time 510(k) submissions are regularly sent...
Jon Speer's picture
Jon Speer
Design controls and risk management processes should be tools to ensure that medical devices are designed, developed, and manufactured to be safe and effective, and to address indications for use,...