Webinar 1: Roadmap to Market Access: Understanding Global Device Regulations
Navigating global medical device requirements can feel 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—and shows how they intersect across quality systems, technical documentation, clinical/analytical evidence, and post-market obligations.
You’ll leave with a clear mental map of what’s required, where the biggest risks typically arise, and how to plan compliant, efficient pathways to certification and ongoing conformity.
Webinar 2: Cracking the Code: MDR, IVDR and UKCA Classification and Indications for Use
Getting the classification of your device right is one of the most critical steps in preparing a successful submission under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Missteps in defining the intended purpose or indications for use can lead to delays, additional costs, or even rejection of your application.
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.
Webinar 3: How to Use Risk Mapping to Set Up Your Project for Success
Risk management isn’t just a regulatory requirement—it’s a roadmap for smarter, more efficient device development. For startups and small companies preparing for MDR or IVDR submissions, effective risk mapping can mean the difference between costly delays and a smooth path to market.
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.
Webinar 4: Demystifying Design Controls and Clinical Planning
For startups and small companies developing medical devices, design controls and clinical planning can feel like some of the most complex—and intimidating—parts of MDR and IVDR compliance. Yet, getting them right from the start is essential for building a strong regulatory submission and avoiding costly delays.
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.
Webinar 5: Building Safer Devices with Human Factors and Usability Engineering
Designing safe and effective medical devices requires more than technical innovation - it requires understanding how real people will use them. Human factors and usability engineering are central to meeting MDR and IVDR requirements, while also ensuring devices are intuitive, reliable, and safe in real-world settings.
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.
Webinar 6: From Prototype to Production: Manufacturing Pathways Explained
Moving from a working prototype to full-scale manufacturing is one of the most pivotal—and challenging—steps for startups and small companies developing medical devices. Under MDR and IVDR, careful planning of your manufacturing approach is essential not only for compliance but also for building a scalable, cost-effective business model.
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.
