We provide consulting services related to the development process of a medical devices - from the concept stage, through the design and testing of the prototype, clinical evaluation to implementation on the medical device market and post-marketing surveillance.

We are experts in:
• Planning and implementing the development process of medical devices for certification (project planning, design, preclinical and clinical tests, preparation for the certification audit)
• Quality management system implementation for manufacturing your medical device in accordance with EN-ISO 13485:2016 standard
• Risk management process of medical devices
• Technical documentation of your medical device development, necessary for CE mark product certification
• Organizing preclinical and clinical investigation required for product certification, including biocompatibility evaluation.

We perform personalized training, support in the process of funding application, manage R&D projects in the MED-TECH industry.

We offer outsourcing of services: ISO 13485 QMS representative, person responsible for regulatory compliance (PRRC), consultant in the area of compliance with MDR requirements.

Please do not hesitate to contact us!

DevGoMed

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