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FMEA Methodology As It Relates To The FDA And Medical Devices 

June 6th, 2014 by Zuhdi Hussein

FMEA for Medical DevicesAlthough it was originally developed for high-risk military assessments, Failure Mode and Effects Analysis (FMEA) methodology has become essential for medical device manufacturers. Firms that want to market products intended for human use must provide some assurance that these products will function as they should.

Although risks are always possible, you need to make sincere efforts to identify and minimize them. Implementing effective FMEA methodologies may help you build a more viable risk management system, especially where your research and development processes are concerned.

Why Do Medical Device Manufacturers Rely on FMEA Methodologies?

The FDA's 21 CFR 820 section 820.30 explicitly calls for manufacturers who create Class II, Class III and certain Class I devices to implement design validation that includes software validation and risk analysis. In other documents, the FDA identifies FMEA methodologies as viable tools for such risk management. Furthermore, this risk-based approach is in keeping with the FDA’s initiative cGMPs for the 21st century and the GAMP 5 recommendation for the validation of software contained in medical devices.

Common international standards, like IEC 60812, also offer guidelines that firms can use to improve their FMEA methods in general. Because these strategies have been around since the 1960s and they're widely utilized, they may facilitate more successful risk management for firms that have little prior experience in the field.

Comprehensive Risk Management

Exhaustive risk management systems may also play critical roles in premarket approvals and 510 k filings. For instance, your evaluation of a specific device should generate a FMEA table that documents different components, potential failure modes, possible hazards, side effects, detectability indicators and effective controls. Compiling such information may provide regulators with additional data that they can use to assess the marketability of your product in relation to FDA 21 CFR and European Union guidelines.

Implementing FMEA Methodology in the Most Effective Fashion

FMEA has been referred to as a bottom-up approach, meaning that it begins with a per-component examination of a device's failure potential. As such, it's critical to institute your FMEA methodology at the beginning of your design endeavors and reassess your products at each subsequent review stage.

Attempting to correct hazards identified by FMEA assessments after you've already created a potentially marketable device is highly inefficient. The failure modes you discover in specific components may necessitate major redesigns or jeopardize the safe operation of related parts and systems. Early risk management, on the other hand, could reduce the costs associated with making corrections.

FMEA risk assessment methodologies can also be applied to manufacturing failures, so the FDA may view discrepancies in your FMEA documentation as indicators of improperly applied or ineffective medical device CAPAs. Creating a better FMEA risk analysis system may improve your ability to identify and eliminate gaps in your compliance strategy as well as sustain the marketability of your products.

Risk assessment helps firms improve their development practices and maintain regulatory adherence. GxP-CC consultants have decades of experience helping firms optimize the way they apply FMEA methodologies. Contact them today to discuss how they can assist you with your product research and development.

Posted in CAPA, Compliance Consultants, European Union guidelines, Failure Mode and Effects Analysis, FDA 21 CFR 820, FDA & European Regulations, FMEA, GxP CC, IEC 60812, medical devices, Risk Management System

About this author:

Zuhdi Hussein

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