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
This is blog post 2 of 4 in our series on Medical Device Complaint Handling. 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. We’ve combined all four posts into one easy to read white paper. Download it here.
Basic complaint-handling process
Before we talk about reporting, we should take a look at the basic complaint-handling process, which has three phases.… » Read more