MTP 4.0 and Computer Software Assurance for MedTech

Many people think Industry 4.0 is just about implementing smart technology and is restricted to a defined set of industries. It is, in fact, not an IT project, but a change management project.

This presentation will explain the holistic scope of Industry 4.0 and highlight the areas it touches in the MedTech space.

Although Industry 4.0 is not mandated, those that do not plan to address the streamlining of processes (both by process change and technological advancement), will be at a distinct disadvantage.

The main part of the presentation will explore CSA (Computer Software Assurance) and how it is a vital piece in the Industry 4.0 maturity model for minimising computer system validation in both a medical device and the systems that support the design and development of medical devices.

This webinar will be presented by Ian Lucas. Ian is a Partner at SeerPharma Pty Ltd and resides in Melbourne, Australia. He has over 35 years of experience developing/implementing computerised solutions and providing practical advice/assistance in validating them. He was previously an Advisory Board Member of the Institute of Validation Technology (IVT) and has presented at many conferences worldwide. Recently, he has been assisting companies in adopting the CSA validation approach and is actively training and educating the pharmaceutical and medical device sector on Industry 4.0.