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Implementing Comprehensive Quality Systems For FDA Medical Device QSR And Other Regulations

May 12th, 2014 by

FDA QSR ComplianceThe FDA’s Quality System Regulation shouldn’t act as a hindrance to medical device manufacturers. While many companies are wary of falling afoul of the compliance guidelines contained in Title 21 CFR sections like Part 820, smart leaders realize that FDA QSR compliance can be a stepping stone to conformity with regulations like ISO 13485 and EU directives.

By creating flexible quality management implementations that compile and track essential information with increased accuracy, medical device manufacturers can drastically improve their ability to acquiesce to a wider range of international and domestic standards.

Globally Relevant Regulations

It can be difficult to choose a regulatory scope to focus on when beginning new compliance efforts. Fortunately, the quality system regulations contained in 21 CFR 820 are widely recognized for their efficacy.

You may not even plan on marketing your devices in jurisdictions that fall under the purveyance of FDA regulators. Nonetheless, implementing an FDA-compliant quality system may give you the capacity to quantify the data you’ll need to maintain legality within your own market. Working with a compliance consulting team that can provide basic quality management system templates, such as those available from GxP-CC, goes a long way towards preparing your firm for its future.

Cost Effective Implementations

Another advantage of creating a comprehensive quality system is that such implementations are often more economical. Although there are definitely similarities between EU Medical Device Directives and 21 CFR 820, major differences become readily apparent upon comparison. Read more about the difference in these two approaches here.

If your system is too limited to evaluate your products against each standard individually, you run the risk of believing you’re compliant when you really aren’t.

Unified compliance systems can also save money by helping manufacturers keep track of how different data should be sorted and utilized. For instance, oversight systems that track product quality, such as production line surveillance cameras or automated batch label readers, often generate far more information than is strictly required for compliance with individual standards.

Combined oversight systems may be able to sort this information more efficiently so that you can approach compliance in a more organized fashion.

Improving Future Output

One of the most obvious advantages of maintaining compliance with FDA Medical Device QSR is that these standards offer an adaptable framework for quality management systems and subsystems in general. Firms that want to implement production, equipment, material, documentation and design controls for purposes other than regulatory compliance may be able to do so by following the QSR.

In addition to potentially gaining a better understanding of pertinent subjects, like audits and the CAPA process, device companies can use their compliance systems to gain further insight into their own business processes and profitability factors.

Within the Medical Device Industry, FDA Medical Device QSR guidelines are critical to doing business legally, and GxP-CC consultants possess the regulatory knowledge and industry experience to help firms maintain compliance efficiently. Learn more about implementing structured quality systems effectively by contacting them today to discuss your options with one of their consultants.

About this author:

Dr. Hussein has over 15 years of experience in the GMP industry as a successful advisor for top medical device and pharmaceutical companies. In 2008 Dr. Hussein was named as an assessor for project management in the “German Society for Project Management” (GPM). Dr. Hussein holds a Master’s in Physics and a Master’s in Biomedical Engineering from the University of Hannover in Germany. He also holds a PhD in Physics from the University of Luebeck in Germany.

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