QFI offers a unique Standards update and review service for medical devices through our StandardsSearch Programme that ensures rigorous and accurate conformity to Standards is achievable.
Different service levels are offered as discrete packages depending on the depth and breadth each standard is applied by a Manufacturer, allowing concentration of effort where it is required.
Among the services offered are:
- Detailed Standard Applicability Report analysing (clause-by-clause application, where necessary) compliance or Conformity which recognises Consensus Standard Requirements/Article 5 1. Council Directives 93/42/EEC; 90/385/EEC; 98/79/EC (as relevant) (for the latter, Common Technical Specifications); Regulations (EU) 2017/745 and (EU) 2017/746 (as relevant) (for the later, Common Technical Specifications); CMDCAS; TGA or other schemes as appropriate
- List of Standards / Special Controls with headline changes
- Applicable Standards Update List
The StandardsSearch Programme consists of an annual StandardsSearch membership fee per product/homologous product group or generic product group covering the following:
- Review of Standards Search form listing Standards applied or application desired, submitted by the client
- Initial examination and review of technical documents submitted supporting application of Standards
- Registration of technical documents in the database
- Correlation of Standards expected to be known to the Manufacturer for each product group
- Detailed Standards Applicability Report