Regulatory bodies have always emphasised the importance of Risk Management under ISO 14971 in the development of medical devices and in-vitro diagnostics. Risk Management activities are critical within the Medical Device design processes and product life cycle. The output of Risk Management activities include key documentation reviewed by regulators which help support the overall risk-benefit of placing a device on the market.
This webinar explores how Risk Management is critical to the regulatory frameworks and provides an overview of the fundamental principles and key standards. In addition, it explores some best practices for implementing risk management activities within your organisation, including post-market considerations.
Initially, the context for Risk Management activities is presented which include an overview of a typical device life cycle and where key risk management activities occur. Next, the Risk Management requirements from the Australian, European and US Regulations are compared, and key requirements highlighted. This sets the basis for how a device needs to show compliance to the regulations, through the ISO 14971 standard for medical device Risk Management. The webinar then discusses the application and relationship of this and other standards to the risk management process. It also covers the changes to the ISO 14971 standard introduced in the 2019 edition, and the impact on medical devices.
To help understand the risk management process further, the webinar provides an overview of the ISO 14971 standard, and steps through the key activities, such as Risk Analysis, Risk Evaluation and Risk Control. It provides some discussions on key concepts, providing examples, and techniques for each of these steps. These help to understand what are Hazards, Hazardous situation, Probability of occurrence, severity of harm, risk estimation, and residual risks. It also touches upon the common confusion between Risk Analysis and Risk Management. Later the webinar covers the risk-benefit assessment, and the required production and post-production activities. Finally, best practices are covered which include a look at how risk management processes fit into the product development design control processes and the key activities required with helpful hints.
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.