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Product development

Consulting services for design and development process of medical devices under ISO 13485 focus on ensuring compliance with international quality management standards specific to the medical device and IVD sectors. These services typically include guidance on quality system implementation, risk management, design controls, validation and verification processes, documentation practices, regulatory requirements, and audit preparation. IVDEXEL assists companies in efficiently navigating the complexities of ISO 13485 certification, enhancing product safety and effectiveness while facilitating a smoother path to market.

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Accelerate your product’s journey from concept to market with IVDEXEL’s product development services. We provide end-to-end regulatory guidance and technical support to bring innovative medical devices and IVDs to life.

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  • Regulatory Pathway Planning: Identify the most efficient route to market.

  • Design Dossier and Technical Documentation: Compile comprehensive regulatory submissions.

  • Risk Management and Usability Engineering: Align with ISO 14971 and IEC 62366 standards.

  • Post-Market Surveillance: Develop proactive compliance strategies.

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Partner with IVDEXEL for a seamless and efficient product development process that prioritizes innovation, safety, and compliance.

User needs

Design Inputs/Outputs

Verification/Validation

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