Progress Report: February 2010
Risk Management Applied to Medical Devices: Complying with EN ISO 14971:2009
With revised standards taking effect on March 1, 2010, now is the perfect time to review the risk management process and changes under EN ISO 14971:2009 (European version of ISO 14971:2007).
Whether a medical device aims at diagnosing a disease, treating the cause or alleviating a handicap, the expectation is that it achieves this goal without harming the patient/user nor presenting an unacceptable risk. The word "risk" and variations of "safe" are cited a combined 105 times in the European Medical Device Directive. Clearly, the demonstration of a medical device’s safety is central to compliance with international medical device regulations.
Editor’s Note: Boost your knowledge of EN ISO 14971 at Risk Management as Applied to Medical Devices – a 1-day training presented by LNE/G-MED. This event takes place in the Washington DC area on June 25, 2010 and is limited to a very small class size.
Reserve your spot today by emailing bruce.seidel(at)lne-gmed.com or calling 301-495-0477. See program details.
The Risk Management Approach (ISO 14971) was developed in 2000 to support safety by defining the detailed objectives, requirements and methods relative to this approach. By March 1, manufacturers should have transitioned to the new European version of EN ISO 14971, which was re-issued in November 2009 with modifications affecting the European appendices). Note that the requirements of the European standard are identical to the ones for ISO 14971:2007.
Risk Management Objectives
Risk Management is defined as the systematic application of management policies, procedures and practices to the tasks of analysis, evaluation, supervision and risk control. Its goal is to enable medical device manufacturers to identify all foreseeable hazards and hazardous situations relevant to a particular device and demonstrate that related risk has been reduced to an acceptable level.
Implementing Risk Management
An evolution of the standard, Risk Management now interacts with nearly all of a manufacturer’s activities, including design, engineering, production, purchasing, sales, quality assurance and regulatory affairs. It’s also a perpetual process, beginning with product design and development and continuing in the field, where user feedback can reveal actual performance. The chart on the following page outlines these steps, which are further explained below:
This step is linked with the new European requirement for actively updating the clinical evaluation of the device. It may include the review of customer complaints (individually and their trends), published literature and public databases on adverse events experienced on similar medical devices and post market clinical follow up. The review of the actual variability of the manufacturing process and the deviations or non-conformities may also be an appropriate way to confirm the corresponding risks.
Risk Management vs. FMEA
To incorporate Risk Management into their Quality Management System, most manufacturers apply methods based on Failure Mode and their Effect Analysis (FMEA), which may be split into Design (DFMEA), Process (PFMEA) and Use (UFMEA). While FMEA is a risk management technique mentioned by the standard, it does not alone address all the requirements of EN ISO 14971.
For a particular device, a risk management file regroups the:
By examining various stages of the product and taking into account both hazards and hazardous situations, EN ISO 14971:2009 seeks to better identify areas of increased risk, allowing manufactures the opportunity to implement effective controls.
Find Out More
LNE/G-MED America offers in-person, online and other customized training on a wide range of certification and quality topics. For details, check out our training schedule or request a customized program.
Contact LNE/G-MED America
- Progress Report - News
- MD Revisions Draft Amendments
- MD Classifications
- ISO 14971:2012
- MDD Revision: Actors, Roles and Responsabilities
- WEEE2 Directive
- Maintaining Compliance
- Revisions to the MDD
- ISO 13485 and FDA
- Controlling Outsourced Processes
- The Notified Body’s Role in Medical Device Certification
- EC Publishes E-Labeling Regulation
- IVD Updates
- Post-Market Phase
- IEC 60601 3rd Edition
- Tech File Evaluation
- Clinical Evaluation
- Recast of IVD Directive
- Own Brand Label Devices
- Software Engineering
- Med. Device Packaging
- Single Use Devices
- Usability Engineering
- FDA Use of ISO 13485
- Risk Management
- IVD Directive
- Switching Notified Body
- 60601 3rd Edition Status
- Regulatory News
- Ask Our Experts
- Free Guide: CE Marking
- Free Guide: IEC 60601 3rd Edition
- Free Guide: EMC Testing
- Free Guide: Brazil MD Approval
- Free Guide: Japan MD Approval
- Free Guide: IVD
- Technical FAQs
- Progress Report - News