Launch your innovation
RegSphere accelerates medical device market entry in the European Union (EU) and United States (the U.S), ensuring compliance and efficiency at every step of the way.
Discover our approach
Meet your dedicated partner
We are your trusted partner every step of the way. From navigating regulatory requirements to ensuring quality and smooth product launches, we provide tailored guidance that turns complex challenges into clear, actionable steps.
What we can offer you
Discover our core services for streamlined market entry, including regulatory affairs, quality management, and product support for compliance and efficient launches.
  • Regulatory Strategy & Classification
    Strategic guidance on device classification and regulatory pathways for EU and U.S. markets.
  • Technical Documentation
    Assistance with technical documentation and regulatory submissions for EU and U.S. markets, including IEC 62304-compliant software documentation.
  • Quality Management System (QMS)
    Support in establishing ISO 13485- and MDSAP-compliant quality management systems.
  • Risk Management & Product Safety
    Implementation of ISO 14971-compliant risk management processes
  • Post-Market Surveillance
    Development of post-market surveillance systems to ensure ongoing compliance and continuous product improvement.
  • Product Management & Business Management
    Launch and maintenance of medical products globally
Experience a personalized approach
We combine regulatory expertise with practical implementation, focusing on innovation while managing compliance and quality. Our tailored approach ensures a successful market launch.
  • Hands-on implementation
    We combine regulatory knowledge with practical implementation strategies.
  • Focus on development
    Clients can concentrate on product development while we manage compliance.
  • Regulatory strategy
    We handle quality and regulatory strategies for efficient market entry.
  • Customized approach
    We act as an extension of your team, providing tailored solutions.
Streamline your market entry
From initial consultation to market launch, we guide you through a clear and efficient process. Learn about the key steps and interactions to ensure a smooth and successful experience.
Discuss your needs and goals.
Create a tailored plan for your product.
Manage compliance, quality, and regulations.
About us
  • My name is Seyma Inceli, co-founder and co-CEO of RegSphere. With over five years of experience in Regulatory Affairs, I help medical device companies achieve fast and compliant market access in the EU and U.S., with a proven track record of successful regulatory submissions. Your success is our priority, and we’re dedicated to ensuring every project runs smoothly from start to finish.
    Seyma Inceli
    Co-Founder & Co-CEO
  • My name is Ramz Sbeitan, co-founder and co-CEO of RegSphere, with over 5 years of experience in Global Product Management, Business Management and Regulatory Affairs, I have succeeded to introduce and maintain complex medical products globally. With my technical knowledge accompanied with strong background in different market needs, we will ensure that your product will launch in plan for your target audience.
    Ramz Sbeitan
    Co-Founder & Co-CEO
Connect with our experts
We are available to address your questions. Kindly fill out the form or utilize the contact information provided below.
info@regulatorysphere.com
Hamburg, Germany
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