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eMedev is committed to supporting our clients in the medical and healthcare industries for Medical Device, Invitro Diagnostics, Cosmetics, Food and Medicines maintaining high standards and providing complete solutions for Quality, Regulatory and Compliance challenges. Preparation and review of regulatory submissions, Registration and conformity assessment applications, FDA registrations and listings, CE marking dossier preparation and review, Strategic Planning, Implement integrated ISO 13485 and FDA quality system requirements (QSR), Processes and Systems reviews, Technical Reviews, Technical dossier reviews, Internal audits, Gap analysis for ISO 13485 Medicine GMP, Supplier due diligence and assessment audits, Product labelling reviews, Advertising Promotional Materials reviews, Regulatory advice and consulting support for post market requirements & Training in Medical Device and IVD regulations, FDA QSR, ISO 13485, Medicine GMP, internal auditors.
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