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About Next Regulatory

Navigating the complex world of medical device regulations can be a significant hurdle for medtech companies. At Next Regulatory, we simplify this process, empowering you to bring your innovative products to global markets efficiently while ensuring compliance. We understand that the challenges are different depending our your company size and stage and we provide pragmatic and tailed approach in the services we provide.

Our Expertise

Next Regulatory provides comprehensive regulatory affairs services, including:

  • Strategic Regulatory Consulting: We develop customized strategies for product development, market entry, and lifecycle management, ensuring alignment with global regulatory requirements.
  • Quality System Compliance: We help you establish and maintain robust quality management systems that meet international standards (e.g., ISO 13485, FDA 21 CFR Part 820) and facilitate market access.
  • Global Regulatory Submissions: We manage regulatory submissions across key markets, including the US (510(k)), EU (MDR/IVDR), and Asia, ensuring timely approvals and market access.
  • Reimbursement Consulting: Guidance to optimize your products’ reimbursement potential, starting from your early prototype.
  • Process Optimization: We streamline your regulatory processes to improve efficiency, reduce costs, and maintain compliance.
  • Regulatory Templates: Curated documentation and tools to navigate regulatory complexities with ease.

 

Yann Cailler

Founder & Principal Consultant

Yann Cailler, founder and director of Next Regulatory, is a seasoned regulatory affairs and quality assurance consultant with over a decade of experience in the medical, diagnostics, and combination product industry. With a comprehensive understanding of global regulatory frameworks and an unwavering commitment to holistic and pragmatic compliance approach, Yann has helped companies of all sizes—ranging from startups to multinational corporations—navigate complex regulatory landscapes and achieve market success.

Yann’s qualifications and expertise make him a key partner for medtech companies:

  • Regulatory Strategy: Proven ability to design and execute tailored regulatory strategies that align with business goals and ensure timely product approvals in international markets.
    Global Compliance: Deep expertise in managing submissions for U.S. FDA 510(k) filings, European MDR and IVDR compliance, and global market registrations, including Japan and other regions.
  • Process Optimization: Skilled in implementing efficient tools and workflows, such as regulatory information management systems (RIMS), to streamline processes and reduce time-to-market.
  • Emerging Fields Expertise: Specialized knowledge in cybersecurity, artificial intelligence, and digital health regulations, making him well-equipped to guide companies operating in cutting-edge areas of medtech innovation.

Yann’s background is engineering complemented with a Master’s Degree in Health Economics and Pharmacoeconomics. In addition to be the author of multiple patents, including innovations in electrophysiological mapping electrode systems, Yann’s academic background is complemented by multiple certifications such as MR Safety, cybersecurity, and reprocessing.

Throughout his career, Yann has:

  • Managed and scaled high-performing regulatory teams, ensuring efficient operations and fostering a culture of excellence.
  • Played a pivotal role in securing regulatory approvals for complex products by developing innovative regulatory and quality strategies.
  • Collaborated with regulatory bodies and cross-functional teams to address challenges, ensuring smooth and successful interactions.

Yann’s approach as a consultant is built on collaboration, adaptability, and a results-driven mindset. He works closely with clients to deliver actionable guidance, helping them turn regulatory challenges into opportunities for growth.

Why Choose Next Regulatory?

We understand that every medtech company is unique. We offer:

  • Tailored Solutions: We develop customized strategies to meet your specific needs and objectives.
  • Proactive Approach: We anticipate regulatory changes and proactively address potential challenges.
  • Strategic Partnership: We work closely with you as a trusted advisor, providing guidance and support throughout the regulatory process.
  • Focus on Results: We are committed to helping you achieve your market access goals efficiently and compliantly.

Ready to bring your medical device to market?

Contact us today to discuss how Next Regulatory can help you navigate the regulatory landscape and achieve your business objectives.