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.