6 Medical Device Compliance Issues That Will Demand More of Your Bandwidth in 2019

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.…

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Medical Device Postmarket Surveillance (PMS): Building a Process

This is blog post 4 of 4 in our series on Medical Device Complaint Handling. We’ve combined all four posts into one easy to read white paper. Download it here.

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.…

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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. 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. Be sure to check out our previous articles on complaint handling and reportable incidents.…

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Is That Medical Device Incident Reportable?

This is blog post 2 of 4 in our series on Medical Device Complaint Handling. We’ve combined all four posts into one easy to read white paper. Download it here.

In our previous blog post, we talked about the basics of medical device complaint handling, including terminology, governing regulations, and how complaints reach companies. In this post we’ll focus on the reporting process.

Basic complaint-handling process

Before we talk about reporting, we should take a look at the basic complaint-handling process, which has three phases.…

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