Advice for the legal compliance of medical devices.
Servicios que ofrecemos:
- ISO 13485 implementation.
- Product risk management.
- Licensing of manufacturer, importer, steriliser or grouper.
- Product qualification and classification.
- Product registration.
- Obtaining CE marking.
- Review of advertising.
- Communications of distribution in the Autonomous Community.
- “In House” products.
- Preparation of technical dossiers for medical devices and in vitro diagnostics.
- MDSAP implementation.
- Clinical and performance evaluation.
We perform value-added audits:
- Internal audits (1st part).
- Supplier audits (2nd part).
- Integrated management system audits.
Training:
• Open courses organised in INGECAL.
• Courses and seminars “in company”.
• Online courses available on the e-learning platform INGECAMPUS.
Have you heard of our IMDC?
Project Manager
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Please contact us and we will get back to you as soon as possible.
Thank you very much.
