Research, development and manufacturing of medical and pharmaceutical products, quality, regulatory compliance and market access, supported by artificial intelligence.
With EAA Med Consulting, experts in regulation and quality systems for medical and in vitro diagnostic devices: ISO 13485 quality management systems and audits with notified bodies, CE marking under the MDR (technical documentation, clinical evaluation, post-market surveillance, ISO 14971, IEC 62304), in vitro diagnostics under the IVDR, and access to international markets, including the FDA.
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