Product

Product Scope of Services The process of product registration in IMED and acquisition of the IRC code in support of import authorization, Review of documentation related to shipments ready for dispatch, with a focus on customs clearance requirements in the destination country, Identification of required quality and compliance testing based on product type and risk […]

Product

Product Scope of Services • Assessment of the product’s regulatory status, including review of medical classification, regulatory pathway, and requirements related to CE marking and Annexes, labeling, Declaration of Conformity (DoC), and the defined intended use according to UMDNS, • Review and assessment of the product’s technical documentation in terms of structure, quality, and consistency […]

Company

Pre-Authorization Assessment and preparation services prior to initiating the formal authorization and import process, with the aim of reducing overall costs and required timelines. Company Scope of Services • On-site visit to the company and production line and facilities to review operational processes against approved documentation, • Assessment of the company’s quality management system in […]