Software use has become increasingly complicated with the expansion of software applications, for example: Artificial Intelligence, cybersecurity, interoperability, mobile medical "apps," home use and remote use. The increasing sophistication and venue for use create new software design validation considerations. In many instances, validation is limited to the immediate use of the software rather than its environment of use, its performance with other software programs and software hacking.

When software causes a problem, fixing the malfunction or "bug" may be more difficult as software becomes more sophisticated, customized by users and placed in a network system. In these kinds of circumstances, it is difficult to decide who is responsible for managing and fixing the software problems. When firms are designing and marketing software, they should be mindful the unknowns that lurk in the future of software regulated as a device by different regulatory authorities.

Rejection of regulatory submissions for the approval for sale of a medical device causes delayed product launch, lost revenues, increased costs and damaged reputation. Software's level of complexity and use is expanding at exponential levels. Likewise the potential risks to health follow suit. Problems with software create a number of different hurdles.

Why attend?

At this event, you will learn about the processes, standards, fault condition handling, and guidelines that are required to minimize the risk of rejected submissions through our training solutions which detail best practice software development for medical devices containing software. You can get insight of how to balance right and achieve better compliance and faster time to market.

Who should attend?

Personnel from regulatory affairs, quality assurance, software design engineers, manufacturing, complaint and hospital risk departments 

 The event comprises of a two-day course and a one-day workshop:

Two-day Course (Aug 30 - 31)

•          When software is considered a medical device?
•          Medical Device Software Regulation – Software Qualification and Classification under Different Regulations
•          Regulatory Strategy
•          Stand-Alone Medical Device Software - Software as a Medical Device
•          Component medical device software- Software as part of a Medical Device
•          Mobile Applications - Medical Device Regulations
•          Design Control - Medical Device Software
•          Compatibility by Design - Hardware and Software
•          US FDA Medical Software Regulations
•          European Medical Software Regulations
•          The IEC 60601 standard and medical device software
•          IEC 60601-1 3rd edition Annex 14 ‘Programmable Electrical Medical Systems’ (PEMS)
•          IEC 62304: Medical Device Software – Software life cycle processes
•          IEC 62304: Risk Classification and Software Processes - Detailed Study
•          IEC 62304 for stand-alone and component medical device software
•          IEC_80002-1- Risk Management – Software
•          Cybersecurity
•          Software Validation

Workshop – Case Study (Sep 3)

•          Introduction of the medical software case
•          Classification based on IEC 62304
•          Selection of IEC 62304 medical life cycle based on the classification
•          Hand on review of the life cycle
•          Case Study - Development of Development Plan
•          Case Study - SRS
•          Case Study - Software Design
•          Case Study - Coding guidelines and Coding 
•          Case Study - Software Problem Resolution
•          Case Study - Software release management

Speaker’s Profile

John Baby is a successful entrepreneur, lecturer, adviser and experienced management consultant with more than 18 years of experience in Medical Device Industry. He has been part of many medical device companies and have successfully guided a number of medical device software products, have got many product regulatory approvals from all major regulated authorities including US FDA, European CE, Singapore HSA and China CFDA.

He is a software expert and also currently a group member of WG3-Software and Medical Device - AHWP, Asian Harmonisation Working Party. John is also part of advisory boards in technology and life-science companies, and Speaker in international seminars and guest lecturer in universities for medical technology and process related subjects. He holds a Master Degree in Computer Science.

Promotion

Group registration for a group of three (3) or more is entitled for a 10% discount.