Software Medical Devices – Considerations for Regulatory Compliance Success

Duration: 60 minutes


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Why watch


Digital Health worldwide has had a massive growth in recent years, including new technologies in the healthcare space for both consumers and healthcare practitioners, such as wearable technologies, health apps and connected medical devices. This growth has also led to changes in the regulatory landscape of medical device software, either as a stand-alone device or within a hardware medical device system. 
The webinar will aim to cover classification of Medical Device Software, especially the challenges with borderline medical devices. It will include an overview of the regulatory pathways to market for Europe, Australia, and the USA and how these have been strengthened. The webinar will also cover key technical considerations for software development, such as use of software standards, Risk Management, establishing a Technical File and Quality Management System to an approved standard. Finally, software specific areas will be covered and the regulatory considerations around them, such as Artificial Intelligence and Machine Learning (AI/ML), Cybersecurity and post-market continual monitoring.

Key Learnings

  •  Classification of software, either as a stand-alone device or within a hardware medical device system
  •  Regulatory Pathways and considerations in key markets
  •  Тechnical considerations to apply to software developmenт
  •  Artificial Intelligence, Machine Learning and Cybersecurity considerations


A full hour of inspirational speaker(s)

Yervant Chijian

Director, Team Lead Medical Devices / IVD, Australia

Yervant provides expert technical consultancy for Medical Device regulatory compliance in major markets, ensuring efficient market access.
Yervant has spent the last 20+ years in the Medical Device field, including both manufacturing and product development. His expertise lies in Regulatory Strategic Planning, particularly in the United States, Europe, Canada, Australia, and New Zealand markets, and in Product Development and Design Controls, specifically in software and with active devices. Coupled with his experience in Manufacturing Processes, Quality Management Systems (ISO 13485 and MDSAP), and Product Lifecycle Management, he brings a comprehensive skill set to support clients navigate through the variety of regulatory pathways and requirements.


Malcolm Pinfold

Associate Director, Medical Devices and IVD, PharmaLex UK

Malcolm provides expert consultancy for both medical devices and in-vitro diagnostic devices. He has expertise in both regulatory requirements and quality management systems and, from his experience in an EU Notified Body, can provide expert support with all device risk classes and quality systems. He has taken a special interest in software and how this is regulated and managed once launched onto the market. He is an acknowledged expert in the application of risk management, both as part of design control and post-market monitoring.
With 15 years’ experience in the medical device arena, he is always ready to share his detailed knowledge.