Course Overview
Medical device software is evolving and growing exponentially. An increasing number of devices contain software as part of their makeup. Getting a software device to market and then maintaining it is extremely challenging. Once developed software is constantly changing to stay up to date with the latest operating systems or security issues. Notified Bodies and Regulators want to see how you are maintaining a high-quality product that puts the end user’s safety first.
This training course will provide you with solutions to the regulatory challenges you face when working with software as a medical device. Once completed, you will have the knowledge to know what must be done to meet Notified Body/ Regulatory requirements. You will briefly touch on aspects unique to software in major regulatory/development areas such as clinical evaluations, investigations, labelling, post market surveillance and risk management.
Eyoto –
n/a
Spirit Digital (verified owner) –
n/a
Cyden –
n/a
Spirit Digital (verified owner) –
Great course to attend before starting a new product.
Individual Booking –
n/a
Imed Consultancy –
Very informative, felt reassured that the speaker had 100% confidence and knowledge in the subject area.
Hirsch Dynamics (verified owner) –
Was very well organized. The portal access and having access before to the materials was really useful. I don’t think anyone in the world could say this is a super interesting topic! But honestly Richard was so engaging, knowledgeable and interesting to listen to.
Individual Booking (verified owner) –
I learned about other useful topics that had not been announced in the course
Individual Booking –
Good course for a general overview of software requirements
Amara Therapeutics –
n/a
Luminate Med (verified owner) –
n/a
CMR Surgical –
n/a
CMR Surgical –
n/a