Webinar
Medical Devices

Roadmap to Market Access: Understanding Global Device Regulations

Startup Edition Webinars series: Webinar 1 - 11 November 2025 - 16:00 GMT

Navigating global medical device requirements can be complex and fragmented

This practical session demystifies the core regulations and standards that shape market access today—EU MDR, EU IVDR, ISO 13485, and MDSAP.

How to plan compliant, efficient pathways to certification and ongoing conformity.
Identifying where the biggest risks typically arise.
Learn how startups and small manufacturers can accelerate growth by prioritizing quality management.
Key points for achieving device certification in the EU.

Speakers

Hear from the experts in this webinar

Speaker

Jason Butcher

Sr. Technical Specialist and Scheme Manager, Vascular Devices

Speaker

Vishal Thakker

Head of UK Approved Body

Register for our BSI Insight Series: Startup Edition Webinars

Join us for this webinar series tailored for regulatory, R&D, and quality professionals, as well as founders of startups and small manufacturers.

This webinar will break down the essentials of MDR and IVDR classification rules and show you how to properly define indications for use in a way that aligns with regulatory expectations.

Through clear explanations and practical examples, you’ll gain confidence in navigating this complex but fundamental part of the conformity assessment process.

9 December 2025 - 16:00 GMT

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In this webinar, we’ll introduce practical approaches to risk mapping that align with MDR and IVDR expectations, while staying realistic for resource-limited organizations.

You’ll learn how to identify risks early, link them to design and development activities, and use your risk map to guide smarter decisions throughout the product lifecycle.

13 January 2026 - 16:00 GMT

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This webinar will break down design controls and clinical planning into clear, actionable steps tailored for resource-limited organizations.

You’ll learn how to connect design activities with risk management, plan clinical evidence in line with regulatory expectations, and document your process effectively to support MDR and IVDR submissions.

10 February 2026 - 16:00 GMT

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This webinar will introduce startups and small companies to the fundamentals of human factors and usability engineering in the context of MDR and IVDR compliance.

You’ll learn how to integrate usability considerations early in development, reduce use-related risks, and strengthen your technical documentation for regulatory submissions.

10 March 2026 - 16:00 GMT

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This webinar will provide clear guidance on evaluating manufacturing pathways, including insourcing versus outsourcing, supplier considerations, and how to align your production strategy with MDR/IVDR requirements.

You’ll learn how to make informed decisions that balance quality, cost, timelines, and regulatory obligations—helping you bridge the gap between early development and successful market launch.

14 April 2026 - 16:00 GMT

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