Online Safety Community

Medical Device Process Validation is the Key Part of a Quality Process

Process validation is one of the essential functions of a quality system for medical devices. Medical device manufacturers who have to stay compliant with regulatory requirements have to obtain premarket approvals (PMA), as well as premarket notifications for both new and modified existing medical devices. The key to all these is medical device process validation.

The FDA standard for medical device process validation is CFR Part 820, Section 820.75(a), according to which, “where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures”.

 

578aeed888d369f92a53d2ce_lifecyclehttps://compliance4all14.files.wordpress.com/2018/02/578aeed888d369f92a53d2ce_lifecycle.jpg?w=150&h=101 150w, https://compliance4all14.files.wordpress.com/2018/02/578aeed888d369... 300w, https://compliance4all14.files.wordpress.com/2018/02/578aeed888d369... 689w" sizes="(max-width: 524px) 100vw, 524px" width="426" height="288" />

The need for medical device process validation First of all, why should medical device process be validated? The rationale for this is spelt out by the FDA: “The organization shall validate any processes for production and service condition where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the product is in use or the service has been delivered”.

Further, medical device process validation helps in a number of ways:

  • It ensures safety of the device
  • Increases customer satisfaction and confidence in the device
  • Reduces wastage from production of medical devices, and
  • Leads to improvements in product quality, processes and design
  • Ensures adherence to product specifications
  • Most importantly, avoids a host of embarrassing and time-consuming activities such as Warning Letters, 483’s, inspections, penalties and the like.
In relation to which regulatory requirements should medical a device process be validated?A medical device process validation has to be conducted in relation to four important standards:
  • The FDA’s Quality System Regulation
  • ISO 9001:2008
  • ISO 13485:2003
  • Relevant and appropriate OSHA standards

What to validate and what not to?Although this question appears complex, the guidelines issued by the Global Harmonization Taskforce (GHTF) serve as a good indicator for this question. It states in simple and unequivocal ways that any process whose output is verifiable, and when this verification suffices and is cost effective, does not have to be validated. Every process that does not meet this criterion has to be revalidated. The Medical Device Quality Systems Manual provides more details on this matter.

When to validate a medical device process?Medical device process validation has to be done both during production and after release, depending on the product design and release. This means that medical device process validation is carried out both when a new product is being manufactured or when there is a need to revise the process, and when defects are discovered after the release into market, when the device has to be recalled and validated.

Views: 44

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

Mark Nilson posted events
4 hours ago
Training Doyens posted events
5 hours ago
Training Doyens posted events
Friday
Adam Fleaming posted a blog post

Having a [baby] is exorbitant and befuddling, notwithstanding for a wellbeing approach master

It is hard to believe that it has been just over since five months since our second son, Lukas, was born on Feb. 3. His mother, Hollyanne, is doing well, which is something to be thankful for, given the excessive maternal mortality rates in the U.S. Lukas is also healthy and growing, albeit sleeping little at night. What is unbelievable…See More
Thursday

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