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 across technical, quality, and regulatory documentation, including identification of existing gaps and deficiencies.