Medical Device Software: Current Developments in the Regulatory World

Duration: 38 minutes


**For more information, please see PharmaLex Privacy Policy.

If you do not wish to receive any communication from us, you may unsubscribe at any time.

Why watch


There has been an insurgence of technologies, products and services within the digital health sector in recent years, which has seen an exponential growth of technologies in the healthcare space for both consumer products, patients and healthcare practitioners. These include wearable technologies, healthcare apps and connected medical devices. This growth also includes software that may fall under the Regulated Medical devices frameworks. The challenge has been to understand if a software fits under the definition of a medical device and if so, how current regulatory frameworks should be applied to these regulated medical device software.
This webinar presents fundamental regulatory considerations for Software which is in a Medical Device (SiMD) and stand-alone Software as a Medical Device (SaMD). It discusses the similarities and differences in the context of medical device regulations and provides examples for each. The webinar first discusses the general definition of a medical device and how it applies to software, including the challenges of applying the classifications and frameworks to the various software types. It covers the regulatory perspectives for the major jurisdictions including the USA, Europe, Canada and Australia. These include the current changes, such as Impact of EU MDR software classification changes, changes to Australian & Canadian classification rules for software, and the US FDA’s Software Pre-Cert Pilot Program. The webinar also compares the regulatory pathways for the various jurisdictions emphasizing how they apply to software.
In addition, the webinar provides an overview of the key standards including IEC 62304 the Software Development Lifecycle Process Standard for Medical Devices, IEC 62366-1 Usability Engineering standard, and application of ISO 13485 Design Controls. These include a focused look at how design controls apply to Software Development, specifically around Iterative processes such as Agile, and product Verification and Validation considerations. 
Finally, the webinar briefly touches upon several hot topics for consideration by medical device manufacturers and software developers. These include Artificial Intelligence (AI) & Machine Learning (ML), Information Security & Privacy, and Medical Device Data Systems (MDDS). Post-market Considerations are also covered to highlight activities to be included within the manufacturer’s processes such as Issue Management, Software Maintenance, and Quality Assurance.

Key Learnings

  •  There is a difference in definition and how regulators view Stand-alone software medical devices with changes to classification by most regulators.
  •  Development of software, including its documentation, should be aligned with mandatory standards such as  IEC 62304 and IEC 62366 which must be applied to your software early in the development phases.
  •  Software V&V must carefully address the design and testing envelope, with the outcomes very clearly discussed in labelling.
  •  AI/ML software and its uniqueness is now being considered by regulators, but no clear guidance has been universally accepted.  

A full hour of inspirational speaker(s)

Yervant Chijian

Team Lead and Senior Consultant

Yervant provides expert technical consultancy for Medical Device regulatory compliance in major markets, ensuring efficient market access. Yervant joined the Brandwood CKC in early 2019, coming from the MedTech industry as an experienced Quality and Regulatory professional. Spending the last 20+ years in the Medical Device field, including both manufacturing and product development, his prior roles include RA/QA Director, Quality Assurance Manager, Operations Manager, Production Manager, and Product Development and Manufacturing Engineer. Utilising his strong technical background and hands-on expertise to provide practical solutions to the challenges faced by his clients in any phase of their product lifecycle.

By implementing strategies which are customer-focused and meet business requirements he brings efficiencies tailored for our clients, whilst meeting the strict regulatory obligations of the medical industry. Yervant’s 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 Electrical technologies. Coupled with his experience in Manufacturing Processes, Quality Management Systems (ISO 13485 and MDSAP) and Product Lifecycle Management, he brings a comprehensive skillset to support clients navigate through the variety of regulatory pathways and requirements.