It’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
The 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
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