The regulation of Medical Devices and Health Products enforces thoroughness in the application of the regulations and the generation of supporting documentation.
The demanding regulatory framework for Medical Devices, currently in the process of change, requires a high level of control over all phases of the product life cycle in order to guarantee patient and user safety (design and development, Product commercialization, production, storage and distribution, installation, service and removal).
An expert consultant from Ambti BST has created this free Webform. By filling out this multiple choice questionnaire, you will find out the level of compliance of your processes and products in IVDR. You will then receive a score and quick feedback on your needs from Ambit BST's Medical Device experts. Thus, you will be able to identify the areas for improvement and strengths of your company in this area.