As the deadline for the Medical Device Regulation (MDR) approaches, many medical device manufacturers are rushing to complete the required tests and evaluations mandated by this regulatory update. The MDR introduces significant changes aimed at improving the safety and performance of medical devices, but the transition has proven challenging for the industry.
The increased demand for testing and compliance has strained supplier resources, revealing a shortage of expertise and capacity. Manufacturers are finding it difficult to secure the necessary testing services and materials, leading to delays and bottlenecks in the compliance process. This strain is compounded by the complexity of the new requirements, which demand a more thorough and detailed evaluation of medical devices than previous regulations.
In this webinar, we will explore the key challenges faced by manufacturers in meeting the MDR deadline and provide practical solutions to navigate this critical period. Participants will learn about the specific tests and evaluations required by the MDR, including biocompatibility assessments, clinical evaluations, and post-market surveillance plans. We will also discuss strategies for optimizing supplier collaboration and resource management to ensure timely compliance.
Furthermore, the webinar will address the gaps in expertise that have been exposed by the MDR transition. Industry experts will share insights on building internal capabilities and leveraging external resources to fill these gaps. By enhancing their knowledge and skills, manufacturers can better manage the regulatory demands and maintain the quality and safety of their medical devices.
Overall, this webinar aims to equip medical device manufacturers with the tools and strategies needed to successfully meet the MDR requirements, despite the challenges posed by limited resources and expertise. By preparing effectively, manufacturers can ensure compliance and continue to deliver safe and effective medical devices to the market.