Software is playing an increasingly important role in the MedTech sector, we see developments in smart devices, embedded software and wearable healthcare technology. We also see that European Regulations are developing to address this technology with increased scrutiny and specific requirements for these products.
This one-day training session is aimed at all companies developing and maintaining these types of products and explores the regulatory basis for conformity assessment of these products and the expected of standards and process to demonstrate ongoing compliance. This course will look at the implementation of IEC62304 in the development of software and software containing devices.
In this one-day interactive course, you will learn how to:
– Examine classification for these products
– Explore the required General Safety and Performance Requirements and the application to the design, development and maintenance of these products
– Examine techniques for market access, selection of critical distributors and good use of clinical evidence
– Working with quality and regulatory teams including demonstration of design process control
– Understand the importance of strong interfaces between the customer facing groups and the design and regulatory groups
– Explore the need for risk management and human factors engineering in this product sector
– Study the application of recognised standards and good practice as well as documentation expectations
Medilink Member cost: £180
Non-Medilink Member cost: £215
To find out more and to book your place, please click here.