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
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).
Requirements for software risk management in Europe
ISO 14971 and IEC 62304 are international standards intended to help you meet regional requirements, such as those imposed by the European Medical Devices Directive (MDD 93/42/EEC) and the EU Medical Device Regulation (MDR 2017/745).… » 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. Read Part 1 here. We’ve combined all three posts into one easy-to-read PDF, plus added some extras. 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. The one(s) you use will depend on your product and company culture, among other things. It would take far too long to go into depth about the options available to you, but here is a list of some of the more commonly used tools.… » Read more