MPD Training Course: Software Development, Control & Validation
14th November 2018 @ 9:30 am - 4:00 pm
MedilinkWM and Acclaim Biomedical Consulting Ltd bring to you practical Training Course designed around the delegate. These intimate sessions are designed to maximise learning outcomes and are created to promote interaction and discussion.
There is a fee for this course, your invoice will be forwarded to you after registration.
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 1 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 Members: £180
Non Medilink Members: £215
Your invoice will be forwarded to you on confirmation of your registration.