Online Safety Community

FMEA in medical devices can work better when mated with ISO 14971

Failure Mode and Effects Analysis (FMEA) is a core aspect of risk management and risk analysis in medical devices. FMEA is essentially about analyzing the reasons for which a problem arises and the effects it has on the system. In the field of medical devices, it is absolutely critical to understand the failure mode and effects because the consequences of not doing this can be disastrous and many times, even fatal.

whats-new-in-risk-assessment-32-638https://compliance4all14.files.wordpress.com/2018/02/whats-new-in-risk-assessment-32-638.jpg?w=150&h=84 150w, https://compliance4all14.files.wordpress.com/2018/02/whats-new-in-r... 300w, https://compliance4all14.files.wordpress.com/2018/02/whats-new-in-r... 638w" sizes="(max-width: 572px) 100vw, 572px" width="572" height="322" />
Required, but not clear about the steps

The FDA only broadly states that risk management has to be built into the manufacturing process. This leaves medical device manufacturers in a kind of quandary, because although the FDA is clear about the requirement for risk management; there is no clear-cut guideline on how this needs to be carried out. This leaves the implementation of FMEA in medical devices something that is at the discretion of the medical device company.

The FDA’s Final Rule on cGMP Quality System Regulation (QSR) is, to quote its own words, “less prescriptive and gives the manufacturer the flexibility to determine the controls that are necessary to be commensurate with risk” (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Postm...). In other words, there is no specific guideline on risk management, using which medical device manufacturers can decide the ways and processes of implementing risk management. The guideline is all the more vague about risk analysis approaches and procedures like FMEA.

Complementarity with ISO 14971Since the guidelines on medical devices FMEA are rather general medical device companies that implement FMEA have to go by a buzzword: implementing FMEA at every level. In this regard, they can work complementarily with ISO 14971, whose guidelines relate to risk management.

Views: 31

Comment

You need to be a member of Online Safety Community to add comments!

Join Online Safety Community

Take our poll!

Take our poll!

Latest Activity

Tytti posted a blog post

Aviation Safety – lightning protection and other lessons from the forerunner in safety

The first ever scheduled commercial air passenger flight took place in 1914 in the US. The flight was 23 minutes long and flew the distance from St. Petersburg to Tampa. Only one seat was available in this aircraft, and it was auctioned for $400 USD (over $5,000 today). Since then the aviation industry has come leaps and bounds, especially in terms of technology and safety, for which it is often held up as a leading example.Today, aviation is considered as one of the safest modes of…See More
1 hour ago
Traininngdotcom-LLC posted events
2 hours ago
Training Doyens posted events
3 hours ago
Manavalan posted an event
Thumbnail

Nebosh course in Chennai at Chennai

July 17, 2018 at 6pm to July 31, 2018 at 7pm
6 hours ago

Forum

5 TECHNOLOGY-BASED LONE WORKER SAFETY SOLUTIONS

ABOUT 75% OF EMPLOYEES IN NORTH AMERICA ARE MOBILE WORKERS. ADVANCES IN COMMUNICATIONS TECHNOLOGY MEANS THESE WORKERS CAN WORK ANYWHERE AT ANY TIME. THESE NEW TECHNOLOGIES ALSO MEAN THESE MOBILE…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 31.

Road Safety Solutions 14 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

Tags: safety, gear, wear, Equipment, &

Started by Enna Henry. Last reply by Jen McDade May 31.

Remote Monitoring

Get "Safe Assets and Sound Productivity" Through Remote Monitoring.Visit:…Continue

Tags: Solutions, People, IoT, Monitoring, Remote

Started by Jen McDade May 23.

Python Condition Objects Tutorial in 2018 1 Reply

If you have knowledge of other programming languages, then you would know the importance of conditional statements. Conditional statements are required for taking decisions. Whenever we operate the…Continue

Tags: course, certification, training, languages, programming

Started by Elena Lauren. Last reply by Jim Chesters May 15.

Power BI Visualization Types

Visualizations in Power BI displays the visual insights from a data. In power bi service a visual can be pinned from reports to create dashboards. Visuals are used in reports.List of visualizations…Continue

Tags: COURSE, TRAINING, BI, POWER

Started by Azharuddin May 15.

Badge

Loading…

© 2018   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service