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!
