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The Steps Medical Device Manufacturers Take To Ensure the Best Performance

The Steps Medical Device Manufacturers Take To Ensure the Best Performance

PMCF

Peter Dong's photo
Peter Dong
·Dec 12, 2021·

3 min read

There is no denying that most of the world’s population has once in their lives needed a medical device. However, medical devices require a lot of assessment and testing before they can be sent out to the market. Nevertheless, with the increase in demand, the medical device industry has been booming, and new devices are being launched into the market almost every day.

This can make keeping up with the new developments in the market quite tough for a manufacturer. If you want to stay on top of the game, conducting a Post Market Surveillance (PMS) is a must for you.

How Does Conducting A PMS Help?

This will allow manufacturers to understand how their products are being used and if there is a necessity to take any corrective or preventive action (CAPA) against them. With such surveillance, you will get all the necessary data, records, and analysis of the device in relevance to the performance, quality, and safety of the device’s whole lifecycle.

The data you gather from this survey will help you with the implication and application of the medical device in the real world. It will tell you about the risks involved and what you might need to change to avoid those.

Most manufacturers incorporate this system in the clinical evaluation and risk management processes throughout the device’s life span. The method that is suitable for your device mainly depends on the device type and classification.

If you are planning to conduct a PMS, you need to develop a plan that caters to the following subject matters:

  • The data they must collect
  • How you analyze the data
  • What are the actions you need to take on the data?

The plan also has to specify the PMCF’s procedures and methods.

What is PMCF?

Now that you know how you can conduct a PMS, you must be wondering what a PMCF is. Short for post-market clinical follow-up, a PMCF mainly refers to the activities that can help provide documentation, data, and proof regarding the device’s performance and safety.

PMCF medical device can be called one of the main components of PMS activities of medical devices. The main purpose of a PMCF is to ensure the clinical performance and safety of the medical device in real-life use. It also allows the manufacturers to analyze the given threat and skillfully manage the same.

PMCF activities mainly occur after the product gets its CE Mark and tends to supplement the existing clinical and non-clinical data gathered from before. All manufacturers are required to implement the PMCF along with statistical relevance in terms of patient numbers, follow-up period, device usage outcomes, and so on.

However, it is important to understand that the regulatory guidance does not specify any format for the PMCF study. Several options are accepted in the community, in addition to formal clinical studies, strategically curated data, and evidence found in surveys and literature. This allows medical experts as well as patients to generate feedback.

This is also one of the reasons why the regulatory guidance can be quite confusing for several medical device manufacturers. In such a scenario, it is best if you partner with a professional, experienced and efficient PMCF solution.

In Conclusion

With the information mentioned in this article, you are now much more knowledgeable about how a medical device’s safety is ensured and what PMCF is. However, if this is too much for you, it is better to find a professional service for guidance.