Quality & Regulatory

Understanding 21 CFR Part 211

What is 21 CFR Part 211? The Code of Federal Regulations Title 21 Part 211 refers to the current Good Manufacturing Practices (cGMPs) set by the FDA for finished pharmaceuticals. These requirements are meant to ensure that finished drug product is handled in a way that does...

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A Guide to Medical Device Risk Management & ISO 14971

Medical device risk management is rightfully an essential component of medical product design and development. When it comes to putting a product on the market, risk analysis is required by law, and regulation checklists must be followed thoroughly. These regulations are carefully outlined in ISO 14971 to...

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An Interview with Gilero’s Vice President of Quality & Business Systems

Kristin Benokraitis joined Gilero in 2007. As one of the team members who has been with Gilero the longest, she has had the unique opportunity to watch Gilero grow, and help fuel that growth, over her tenure with the company. Kristin herself has grown too, serving in...

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The Importance of Proper Medical Device Labeling

What Is Medical Device Labeling? Medical device labeling refers to all of the information that is provided to the consumer with the device itself. This includes symbols, warnings, instructions, and control labels applied to the device or incorporated into the design by color coding, printing, machining, or...

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Medical Device Quality Control vs 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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