Product Development in Accordance with ISO 13485
Secure. Compliant. Ready for the market.
The development of medical devices requires the right balance of innovation, user-friendliness, technical expertise, and regulatory compliance. At Sedax, we combine all of these capabilities to develop safe, effective, and market-ready solutions that meet the needs of users, patients, and regulatory authorities alike.
Providing Clarity - Right from the Start
User Perspectives That Enable Safe Innovation
Many medical devices fail not because of the technology itself, but because they cannot be seamlessly integrated into everyday clinical practice. With our human-centered design approach, we directly involve healthcare professionals and end users in their actual work environments. By combining observation, contextual research, and design thinking methods, we gain a deep understanding of real user needs and identify key challenges in the context of use.
The result is a solid foundation of user-centered insights that support ISO 13485-compliant development and lead to products that are intuitive to use, effective, and safe in everyday clinical practice.
The foundation for safe, compliant, and user-centered medical devices
Successful medical device development begins with clearly defined requirements. During the design input phase, we translate user needs, regulatory requirements, and insights from risk management into structured and actionable specifications.
By integrating technical, clinical, and regulatory perspectives from the very beginning, we create a solid foundation for efficient development. This allows us to ensure compliance with ISO 13485 while consistently focusing on the product’s future use and the needs of its users.
From Requirements to Validated Product Solutions
Once the requirements have been defined, we systematically translate them into verified, market-ready product solutions. Each step follows a structured process that supports certification and regulatory approval. Through targeted verification and validation, we ensure that all requirements are efficiently met. The result is a compliant, reliable, and economically viable medical device whose design has been verified and prepared for a structured handoff to the design transfer phase.
Smooth Transition to Production
Once the design has been finalized, the Design Transfer process ensures that all development results are transferred to series production efficiently and in compliance with standards. As part of this process, we prepare all design outputs for manufacturing and define stable, validated production processes.
Through targeted pilot production and structured testing approaches, we minimize risks and accelerate your time to market. This creates a reliable foundation for scalable, production-ready manufacturing.
Coordinated Litigation
A Coordinated Development Process as a Key to Success
ISO 13485-compliant development requires more than just technical expertise. It demands clear processes, effective management and coordination, as well as consistent professional guidance across all disciplines involved.
Through our proactive project management, we ensure that requirements, risks, schedules, and stakeholders remain aligned throughout the entire development process. Engineering, quality management, manufacturing, industrial design, and after-sales aspects are integrated into a single, structured process.
This results in a transparent, efficient, and compliant development process that combines safety, quality, and market readiness, reduces complexity, and accelerates well-informed decision-making.
Erfolgreiche Medizinprodukte in der Praxis
Von der Nutzeranforderung bis zur Zulassung: Unsere Referenzprojekte zeigen, wie wir innovative Medizinprodukte entwickeln, regulatorische Herausforderungen meistern und sichere Lösungen für den klinischen Alltag schaffen.
Smart Med Cell
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Berkol® Multigrinder
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Einspritzprüfstand Dragon
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LABWORX Serie
Sedax unterstützte Groninger bei der Entwicklung der Designstrategie und des Produkterlebnisses für eine neue Generation von Abfüllsystemen. Das…
ULSAN21 Wasserstoffverflüssigungsanlage
Als integrierte Erweiterung des Engineering-Teams von Linde stellte Sedax ihre Expertise in den Bereichen Engineering, Simulation und Konstruktion zur…
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We combine industrial design and engineering to develop solutions that create real market value. As your strategic partner, our co-creative teams transform your vision into scalable success, from the initial sketch to full-scale industrial implementation.