Date to be announced
Contact us for more infoTRAINING TIMES
Understand each step of the NB review process, responsibilities, and expectations to strengthen your submissions.
Get up to date with the latest regulatory framework and learn how EN ISO13485:2016 supports compliance.
Use the GSPR checklist and proven strategies to manage risks, generate evidence of conformity, and prepare high-quality documentation.
Gain the practical tools and regulatory insights needed to streamline approval and ensure market access for your medical devices.
Two days of expert-led Zoom sessions packed with discussions, Q&As, and real-world scenarios.
All slides, tools, and supporting materials available in our CLIENT ZONE before, during, and after the course.
Receive a digital certificate (also Linkedin-ready) that verifies your skills in strategic trial planning.
Gain a comprehensive overview of the application and review process. Understand where the responsibility begins and ends.
Apply ISO 13485 and 11608 to achieve a good submission
Using the GSPR checklist to manage your design and development file
Understanding risks, requirements, and standards in the context of evidence
Design and development activities necessary for a successful NBO
Designed for professionals who want to enhance their expertise and advance their careers
Health Sciences and Medical Devices Consultant
James Pink has over 25 years of experience in the medical devices industry including 10 years as a healthcare technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assuranceprograms for active and non-active implantable and combination products. James is a contributor to several medical device standards committees including ISO13485, ISO 14971 and various product-related standards.
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“I am very satisfied with the course. The training was extremely valuable, and James's expertise and ability to convey information clearly made the experience engaging and informative. I particularly appreciated the use of real-world examples, which helped contextualize the material and enhance understanding.”Carol Frid
“The knowledge of the trainer, the white board which makes it interactive and alive”Saoudatou Bah
“Very logical way to present complex regulation / requirement Like the use of example”Jennifer Maillard