When preparing your medical device for a global submission, there are many factors to consider from developing a testing plan to keeping up with regulatory standards and much more. While it can be daunting to move forward with a global submission, there are resources and partners that can support you from start to finish, ensuring you are taking the right steps to achieve success.
In this webinar, Dr Bob Przygoda, Research Fellow at Adventure Biocompatibility Consulting, takes a deep dive into the global submission process. As an active member of ISO committees in addition to extensive experience in the medical device industry, Przygoda brings a wealth of knowledge and a unique perspective to this topic and provides valuable considerations for anyone considering a global filing strategy.
Przygoda explores how data and test plans are utilized, leveraged, and adjusted for regulatory bodies, as standards and regulations continue to evolve. He also walks through a global submission case study, starting from initial submission, and going all the way through to the first round of required changes and updates. Following the product cycle provides an opportunity to learn about potential challenges that may face your device and how to avoid or overcome them.
If you are considering a global filing or anticipate adjustments to your current strategy, this webinar will provide insights to help guide plan design, and decision-making, to support your submission. Watch the webinar here.
Established in December 2000, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable companies in the pharmaceutical, biotech and medical device industries worldwide to advance discoveries and deliver groundbreaking treatments to patients. As an innovation-driven and customer-focused company, WuXi AppTec helps our partners improve the productivity of advancing healthcare products through cost-effective and efficient solutions. With industry-leading capabilities such as R&D and manufacturing for small molecule drugs, cell and gene therapies, and testing for medical devices, WuXi AppTec’s open-access platform is enabling more than 3,900 collaborators from over 30 countries to improve the health of those in need – and to realize our vision that “every drug can be made and every disease can be treated”.
For more information, please visit: http://medicaldevice.wuxiapptec.com/