AFT Medical Devices Ltd

 Consultancy Services

Quality Systems

Regulatory Affairs

CE marking for all your products, including design dossier construction and review. Advice about choice of a Notified Body use to obtain tour registration of the CE mark.

Advice about additional International regulatory requirements with different countries, including all preparation, strategy, liaison and registration support.

Advice and support and dossier construction to obtain Reimbursement for your devices for entry in to the health care provider market. Liaison with the reimbursement authorities for approval.

Regulatory Affairs
Independent Auditing
Business and Management Control
Training
Product Development
Part/Full package service

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