Medical devices
Preparing device documentation requires identifying the product, its stated classification and who holds each responsibility.
Medical devices
- Defined intervention
- A basic review of the organization of agreed product and supplier documents and the stated classification. Manufacturer, importer and registration-holder responsibilities are distinguished; a classification opinion is not included.
- Basic-review deliverable
- An inventory of reviewed product and supplier documents, with general observations on organization, stated classification and documented responsibilities.
- Separately quoted services
- Technical product-documentation assembly, supplier documentation and operational support, quoted separately.
Terms and conditions apply. The written proposal defines sites, documents, hours, deliverables, exclusions, validity and payment terms. Additional services and official fees are quoted separately.