What Goes Into Quality Assurance For Medical Devices

February 20th, 2014 by

Medical Device Quality AssuranceQuality assurance (QA) isn’t something implemented solely for consumer satisfaction. In most industries, including that of medical device manufacturing, your QA efforts have very real effects on your ability to legally conduct business in the United States, EU and other global locations.

In some cases, meeting quality management regulations may be more difficult using only in-house resources. Learn how many life science firms benefit by outsourcing their QA tasks by clicking here, or read on to learn more about the regulation hurdles you may face when bringing your device to market.

Meeting The Requirements Of Global Regulating Authorities

The U.S. Food and Drug Administration isn’t the only regulatory body engineers and product designers must keep in mind. With global distribution, authorities such as EU’s European Commission and the International Organization for Standardization also publish abundant, complex rules pertaining to the manufacturing, packaging, marketing, distributing and validation of medical devices.

Firms that attempt to perform complicated QA tasks on their own may experience some difficulty. This is especially true of smaller manufacturers because compliance with FDA and EU rules can be time-consuming.  Many companies, regardless of size, find it hard to pull their skilled staff away from their regular tasks to deal with all of the numerous steps involved in meeting regulations, even when one takes into consideration that the majority of companies nowadays have dedicated QA departments.

Covering Every Aspect of Manufacturing

Medical devices must be subjected to a litany of tests and suitability procedures to ensure they meet all legal requirements. In addition to clinical trials complete with adverse reaction and causation assessments for the devices themselves, the materials used for the manufacture of the devices as well as the manufacturing processes employed must also meet regulations.

The processes used to create devices and pharmaceuticals are often largely automated, and material sourcing may be widespread. It’s best to implement QA validation at each stage of the manufacturing process so as not to miss any potential violations.

Understanding Regulatory Scope

Remember, quality assurance applies to more than just the actual devices you create. Various regulatory bodies have created guidelines on topics as diverse as the supply of instructions for use and acceptable procedures for auditing.

The majority of guidelines and regulations are deliberately vague, due to the fact that they are written to suit the requirements of hundreds if not thousands of companies in the pharmaceutical and medical device industries. The regulatory authorities cannot take the specificities if individual companies into account. In the face of regulations that are very broad, and vague in many areas, some firms find it more beneficial to turn to reputable third parties for QA consulting. Learn more about implementing comprehensive qualification and validation in your production facilities here.

GxP-CC helps companies with the complexities of attaining and maintaining compliance in the industries of medical devices, pharmaceuticals and dental labs. Contact this global group of compliance experts to help you meet the many requirements necessary for your product.


About this author:


For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.

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