In the June issue of InCompliance Magazine I provide advice in an article on how to remain current on medical electrical device standards (including those in development) and regulatory guidance documents. I start up at the International level (IEC & ISO) and then also discuss the US (FDA), Canada (Health Canada) and the EU (Notified Bodies under the MDD currently and in process of transitioning to the MDR). I discuss the structure of the IEC 60601 standards series, what Technical and Sub Committees under IEC and ISO these standards are under and also discuss some of the related standards such as IEC 62304 (Software Lifecycle Processes), IEC 62366 (Usability), etc. Part of what makes things hard for medical device manufacturers on top of all the changes to standards is there is a lot of change going on in the regulatory and quality system space as I discuss some of the challenges medical device manufacturers are currently facing over the next couple years.
View all the articles I have written for InCompliance Magazine.
I hope you enjoy this article and if you have any questions please feel free to contact me at Leo at EisnerSafety dot com or schedule a call with me.