Medical Devices Regulations
BioTop Medical provides tailored advice on certification regulatory strategy for medical devices as well as hands–on support with the quality management system, the preparation of the device Technical Documentation and the compulsory regulatory documents which must be included in the file. We provide for our clients, customised and cost-effective solutions, to market their medical devices in the European Union and North America.
We stay abreast of the latest regulatory changes and changes to standards, and keep our clients informed. We facilitate the task of our clients to make the necessary changes to their systems and devices to ensure continuous regulatory compliance.