Quality & Regulatory

The Difference Between Medical Device Quality Control & Quality Assurance

The last thing a medical device manufacturer wants is for a piece of equipment to malfunction once it gets into the hands of a clinician, patient or caregiver. With such high stakes, the emphasis on quality when it comes to this form of design and manufacturing is...

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The Importance of a Manufacturing Quality Plan

What is a Manufacturing Quality Plan? The importance of a manufacturing quality plan can’t be understated in any field, but it’s particularly important in the medical device industry. A quality plan for medical device design and manufacturing is required by the FDA and the ISO 13485 framework....

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FDA 510(k) Submission Process: An Introduction & How-To Guide

What is a 510(k) submission? A 510(k) submission is a type of regulatory submission made to FDA called a Premarket Notification. In a 510(k), substantial equivalence to a predicate device on the market must be demonstrated. In other words, the medical device in question must be at...

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IEC 60601-1-2 4th Edition

By: Genine Grant, Program and Quality Manager for Integrated Systems at Gilero IEC 60601-1-2 Ed 4:2014 is now in full force.  The initial reaction to a change in regulatory requirements, significant or otherwise, is usually “DARN IT! Just when I finally got the hang of this thing...

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