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post market surveillance | MDR

Best Practices and Processes for Integrating CERs and Post-Market Surveillance Under EU MDR

The EU MDR date of application has come and gone, and most manufacturers are well aware of the new requirements. However, awareness does not necessarily equal effective implementation. One of the main challenges of MDR compliance is creating a strategy that integrates the work of multiple teams, including regulatory, quality, risk management, clinical, and more.
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post market surveillance | medical device | IVD | ROW

Canada Regulations News for Medical Devices and IVDs

In case you missed it, the Medical Device Regulations in Canada quietly got updated in December 2020. The new regulation intends to boost post-market safety and requires manufacturers to submit a summary report, which is similar to the post-market Periodic Benefit-Risk Evaluation Report (PBRER) required for pharmaceuticals in Canada. This new requirement goes into effect on 18 Dec. 2021, which is fast approaching.
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Quality Management System | post market surveillance

Integrating Post-Market Surveillance Into Your QMS

Now that medical device manufacturers have begun to implement MDR-compliant post-market surveillance (PMS) systems, it is a good time to take stock of common areas of difficulty and inefficiency, and consider how best to address these. Even manufacturers who are continuing to place their devices under extended MDD certification have been required to comply with MDR post-market requirements since May this year.
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post market surveillance | MDR

Post-Market Surveillance: A Concise Overview of Requirements

Following the May 2021 deadline, medical device manufacturers now have an MDR-compliant post-market surveillance (PMS) system in place. However, there are still many issues and questions around this topic which need addressing.
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post market surveillance

No Time for Common Sense

Last week, I had a computer issue...not a big issue, more like an annoyance. Nevertheless, I dutifully called our IT support and after a couple of hours of investigation, we determined that the problem could be solved by one of two solutions; change the battery or change the mother board. The manufacturer of my machine was notified and was sending me a battery to change. The next day, a technician contracted by the manufacturer called me to say that he needed to come to my house to change the motherboard. This didn’t make sense to me. I said that we should wait to try the battery solution first. I cited three reasons: • It was the cheapest solution. • I could do it myself. • It was the less risky option. The conversation between the technician and myself went like this: “Ma’am, I’ve got this ticket to close, I’ve got to come to change the motherboard.” Me: “Can’t we wait one more day to see if the battery change solves the problem?” “Ma’am, are you saying that you’re refusing to let me close the ticket?” Me: “No, I’m just saying that we shouldn’t waste the motherboard.” “All that I want to do is close this ticket and I’m going to close it today. If I can’t come to change the motherboard, I’m going to close the ticket anyway.” Me: (reluctantly) “I’ll be home all afternoon.” “OK, now I’m happy.” This is a prime example of the technician being so consumed with his small part of the world, that he doesn’t have the power to use common sense. He doesn’t even care to try to use common sense. He doesn’t consider the low cost solution, the risk to my computer, or even about the best way to provide customer service. He is only focused on one thing – closing his ticket. Now, I know that it’s not this guy’s fault – he’s only responding to external stimulus that provides a reward for closing tickets. That’s his job, only closing tickets. He doesn’t consider the big picture – like being involved in post market surveillance, true customer service, understanding the real problem to feed back data to the manufacturer or even the recurrence rate of this problem. He is rewarded for closing tickets – it may even be linked to his pay or a promotion. If you are in a position to provide guidance, direction or coaching to individuals or a team, make sure that you give them the tools and autonomy to look at the big picture. Allow them to make decisions and apply common sense – they will save your company money and provide true customer service.
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