ISO 14155:2026: What Medical Device Teams Need to Know
August 31, 2026
Watch our 30-minute briefing on the regulatory changes affecting medical devices across the product lifecycle.
Medical device regulatory requirements are changing at both ends of the lifecycle. Submission requirements are evolving. Quality system expectations are shifting. Post-market reporting requirements continue to change. And renewal and recurring-reporting obligations keep running across every market where your products are sold.
The challenge is not simply keeping track of each change. It is understanding how they fit together and what they mean for your regulatory strategy and workload.
In this recorded webinar, Alexia Haralambous, VP of Regulatory Affairs, and Mark Cox, President of AlvaMed, provide a focused look across the major markets and connect the changes affecting products coming to market with the obligations that continue once products are approved.
Mark Cox is President and Founder of AlvaMed and has more than 30 years of experience advising medical device companies across the product lifecycle. His work has spanned the development and introduction of new medical technologies, due diligence, technology strategy, and operational and business considerations affecting MedTech companies in North America and Europe. Mark founded AlvaMed to provide integrated regulatory, quality, clinical, and business support to medical device companies. He holds a BE in Metallurgy and Materials Science from Imperial College London and an MS in Materials Engineering from MIT.
Alexia Haralambous has more than a decade of regulatory experience spanning FDA, the medical device industry, and consulting, including serving as a lead reviewer within FDA’s Center for Devices and Radiological Health (CDRH). She has led regulatory strategy and submissions for medical devices across the product lifecycle and has supported global regulatory activities in the US, EU, UK, Canada, Australia, Japan, China, and other major markets. Her experience ranges from early-stage companies to multinational MedTech organizations and includes both new-product development and post-market regulatory activities. Alexia holds BS and MS degrees in Biomedical Engineering from Johns Hopkins University and is Regulatory Affairs Certified (RAC).
Register to access the full recording.
