Medical devices
Sanitary products are very varied, so it is necessary to fit them well into the standard to implement the necessary requirements for their legalization and placing on the market. Medical devices are, among many others, surgical masks, diagnostic or pregnancy tests, glucose strips, materials used in medical operations, implants, health-related computer programs or machines that facilitate recovery from injuries.
If you have created or developed a new medical device, if you want to import or export a medical device, we give you solutions.
The services we offer:
- Legal analysis of the medical device and its legal framework.
- Communication of placing on the market of medical devices when they are class IIa, IIb and III.
- Communication of authorized representatives.
- Preparation and revision of labeling and instructions for use.
- Elaboration through our specialized partners of technical documentation.
- Analysis and management of the CE marking that must be issued by a notified body, as well as a declaration of conformity.
- Determination of tests and legal requirements for placing the medical device on the market.
- Free certificate of sale for the export of the medical device.
- Advertising and promotion: legal limits, analysis of advertising campaigns for TV, radio, social networks, press and professional meetings.
- Advice on quality matters for the implementation of ISO standards.
- Product development, distribution and commercialization contracts. Confidentiality contract.
- Management and processing of the prior authorization of manufacturing facilities by the Spanish Agency for Medicines and Health Products for manufacturers of health products.
- Management and processing of the import license by the Spanish Agency for Medicines and Health Products and the prior authorization of health product import facilities for importers of health products.
- Communication of the activity of health product distributors to the regional health administration.
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