Medical Device Incident and Adverse Event Reporting Timelines in 6 Major Markets

heart monitor with patient and doctorIt’s 3:00 p.m. on Friday and you’re ready for the weekend after a busy week. All of a sudden you are jolted back to reality by an email about a serious incident at a French hospital involving your company’s heart monitor. Details are sketchy and somewhat lost in translation. It’s now 9:00 p.m. at your office in Europe. They are closed for the weekend and you can’t get more details. Can it wait until Monday?

If you’ve been in your role for some time, you already know that incidents such as this do occur…and you have no control over the timing.…

» Read more

6 Medical Device Compliance Issues That Will Demand More of Your Bandwidth in the Next 12 Months

2019 JourneyThe next 12 months are sure to be a wild ride for medical device RA/QA professionals. There’s a lot going on in the world of regulatory compliance and there is little doubt that your workload is about to increase – you may have seen it happening already. Here’s what we are hearing from our clients about issues they expect will consume more of their precious time this year.

1 – Internal audits and gap assessments

The new European medical device and in vitro diagnostic regulations (EU MDR and EU IVDR, respectively) will certainly demand more attention from regulatory professionals in 2019.…

» Read more

Medical Device Postmarket Surveillance (PMS): Building a Process

This is blog post 4 of 4 in our series on Medical Device Complaint Handling. In our previous three blog posts we talked about the basics of medical device complaint handling and incident reporting, and also provided a primer on how deeply to investigate complaints. In this fourth and final post, we’ll dig a little deeper and talk about developing an effective internal postmarket surveillance (PMS) process. We’ve combined all four posts into one easy to read white paper. Download it here.
» Read more

To What Extent Should You Investigate That Medical Device Complaint?

This is blog post 3 of 4 in our series on Medical Device Complaint Handling. Our first post covered the basics and the second post talked about reportable incidents. In this post we will focus on complaint investigation. We’ve combined all four posts into one easy to read white paper. Download it here.

Complaints come in many flavors and require different levels of attention.

While there are no hard and fast rules for determining how deeply you should dig into an issue, in this article we provide guidelines to help you add some structure and context to the process you develop.…

» Read more
1 2