Historically, medical device developers often opted to bring new products to market in the EU first, as obtaining a CE mark was perceived to be faster, less expensive and more predictable than getting US FDA clearance or approval. With the introduction of the EU’s Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), the paradigm has shifted, and an increasing number of medical device companies are prioritizing the US market. However, the decision of where to launch first must be guided by more than just regulatory requirements.
In an evolving global regulatory landscape where technology is advancing rapidly, medical device developers need to adopt a holistic approach to aligning their product development and go-to-market strategies to optimize the likelihood of regulatory and commercial success. In this webinar, the featured speakers will explore key considerations for prioritizing markets and optimizing the path to product launch.
Join this webinar to gain insights into:
- The comparison of the regulatory landscapes for medical devices and IVDs in the EU and US
- Risk classification of medical devices and IVDs in the EU and US and its impact on product development and associated requirements
- How to develop a rigorous clinical and regulatory plan to support your priority market
- Guidance on aligning product development and go-to-market strategies
- Real-world examples that bring these key considerations to life
Speakers
Matthew Nowland, Vice President, Regulatory Affairs, MedTech, Premier Consulting
Matthew Nowland is a GxP Regulatory, clinical and quality assurance professional with more than 25 years of experience providing regulatory and quality assurance services for healthcare companies, including medical device and pharmaceutical companies. He has prepared and managed several successful global product registrations (US, EU, APAC) including premarket approval (PMA), 510(k), New Drug Application (NDA) and Biologics License Application (BLA) submissions.
He is knowledgeable in both medical device and drug development, good clinical practice (GCP), good laboratory practice (GLP) and good manufacturing practice (GMP) regulations. Mr. Nowland has developed and advanced innovative technologies from surgical robotics to molecular diagnostics, biologics, blood products and all classes of medical devices, both therapeutics and in vitro diagnostic (IVD) studies including LDTs.
He has developed, executed and managed global quality assurance programs at various healthcare organizations and has experience in assessing the compliance of the conduct of clinical research/development activities to applicable regulations and guidelines, scientific protocols and standard operating procedures (SOPs).
Message Presenter
Michael Edwards, Senior Director, Regulatory Affairs, MedTech, Premier Consulting
Michael Edwards is a Senior Director of MedTech Regulatory Affairs at Premier Consulting. Premier Consulting is a strategic product development and global regulatory consulting business unit of Premier Research, dedicated to supporting the specialized needs of emerging biotech, specialty pharma and MedTech companies. Premier Research is a leading clinical research company that’s Built for Biotech℠ and Made for MedTech™.
Michael has more than 25 years of experience in regulatory affairs and quality assurance acquired within the medical device and clinical research industry across a diverse range of medical device technologies and therapeutic disciplines, and organizations from start-ups to multinationals.
Michael’s expertise spans the complete product lifecycle including clinical research, design, development, technical support, project management, operations and business development in the medical devices sector. His knowledge of the device development process combined with the regulatory requirements, enables him to provide a balanced interpretation of the pre-market and post-market needs and expectations of regulatory authorities.
In his current role, Michael provides regulatory, quality and technical expertise to clients and sponsors to help bring their products to market safely, effectively and efficiently. His key strengths include developing, formulating and implementing regulatory strategies for device development and pathways to market to meet both existing and new regulations, standards and guidance documents.
Prior to joining Premier Consulting, Michael has held various senior management positions in regulatory affairs, quality assurance and technical with high-profile, international medical device and clinical research organizations.
Message PresenterWho Should Attend?
This webinar will appeal to senior professionals from Medtech companies involved in:
- Clinical trials
- Clinical operations
- Drug development
- Preclinical trials
- Project management
- Regulatory affairs
What You Will Learn
Attendees will gain insights into:
- The comparison of the regulatory landscapes for medical devices and IVDs in the EU and US
- Risk classification of medical devices and IVDs in the EU and US and its impact on product development and associated requirements
- How to develop a rigorous clinical and regulatory plan to support your priority market
- Guidance on aligning product development and go-to-market strategies
- Real-world examples that bring these key considerations to life
Xtalks Partner
Premier Consulting
Premier Consulting is a strategic product development and global regulatory consulting company dedicated to helping biotech innovators transform their life-changing ideas and breakthrough science into new medical treatments. Our end-to-end solutions in strategy, regulatory, nonclinical, CMC, quality, and commercial help sponsors build and execute development plans that meet regulatory requirements and deliver results for sponsors and the patients they serve.
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