Optimizing Medical Device Life Cycle Management: Navigating Regulatory Pitfalls and Enhancing Compliance Across Global Markets
Joy Greidanus, Director – Medical Device SME
Dr Pratibha Mishra, Manager/Sr. SME, Medical Device Services
Celegence
In the highly regulated field of medical device manufacturing, achieving and maintaining regulatory compliance throughout the product life cycle is an essential obstacle. This seminar will delve into the common gaps observed in medical device life cycle management processes from a regulatory standpoint, offering insights into how manufacturers can enhance their practices to mitigate risks and ensure compliance across key markets including the US, EU, UK, Australia, Canada, and beyond. The expert speakers/panelists will cover critical aspects of the medical device life cycle, spanning from design and development to post-market surveillance, and discuss practical strategies and best practices for navigating regulatory complexities, addressing challenges, and avoiding pitfalls in audits conducted by competent authorities. By leveraging real-world examples and case studies, this session aims to empower attendees with actionable insights to optimize their regulatory strategies and drive operational excellence in medical device manufacturing.
Key Learning Objectives:
• Understand common gaps and pitfalls in medical device life cycle management processes from a regulatory perspective.
• Gain insights into best practices for enhancing regulatory compliance across various stages of the product life cycle, including design, development, clinical strategy, post-market surveillance, and quality management systems.
• Learn practical strategies for navigating regulatory requirements in key markets to ensure successful audits and continued market access.