Service
CE marking for Medical Devices and In Vitro Diagnostic Medical Devices
Establishment of QMS according to ISO13485 Preparation of technical documentation
Holland Innovative is a project agency specialised in project management, reliability engineering, problem solving, data analysis and medical product development. We execute projects for large multinationals, SMEs and tech start-ups.
Within the HI MedTech team, consisting of QA/RA, Project Management, and Clinical Evaluation experts, we support companies to bring medical devices to the market. We are passionate about supporting the creation of relevant, high quality products that meet both the regulatory and customer requirements.
Our key areas of expertise include: ISO13485, MDR & IVDR, ISO14971, ISO14155
VALUE CHAIN
E-HEALTH
Service
CE marking for Medical Devices and In Vitro Diagnostic Medical Devices
Establishment of QMS according to ISO13485 Preparation of technical documentation
Expertise
Establishment and implementation quality management system compliant with ISO13485
Expertise
(In vitro diagnostic) medical devices: regulatory expertise
Regulatory advice for manufacturers of (in vitro diagnostic) medical devices; from D&D through verification/validation to the market