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 the first in a two-part blog series on risk management for medical device software. In our next post
we take a look at the specific FDA and European risk requirements.
In our first post we talked about international risk management standards and guidance applicable to medical device software, including the ISO 14971 and IEC 62304 standards. In this post we will discuss specific compliance requirements in the US and Europe for medical device software paired with hardware, and stand-alone Software as a Medical Device (SaMD).… » Read more
Software itself is not risky. Nobody gets directly injured by bad code or a poorly designed UI and, unlike hardware, software does not fail randomly.
That being said, software can definitely expose someone to a hazardous situation because software is viewed to have 100% probability of failure when it does occur. Therefore, this makes software rightfully subject to risk management oversight, including special considerations for software-controlled medical devices.
In this post, we’ll cover the basics of risk management for embedded software or stand-alone Software as a Medical Device (SaMD), so you have an understanding of what is required before, during, and after coding.… » Read more
This is the last installment of a 3-part blog series on risk management. Our first post
covered the basics so start there if you need a refresher on ISO 14971. Our second post focused in on risk management planning
and in this post we will talk about tools you can for risk evaluation. Download it here.
Unless you have prior experience with risk management, it can be perplexing to figure out which risk evaluation tools are best suited to your situation. There are many options, each with pros and cons.… » Read more