QUALITY & DOCUMENTS
Check the holder, site and product behind each document
A certificate or report is useful when it can be linked to the correct legal entity, manufacturing site, device configuration and current project.
THREE BASIC CHECKS
Read the scope before relying on the document
Who holds it?
Check the legal holder, certificate or report number, issuing body and current status.
Which site does it cover?
Match the stated scope with the manufacturing location and work relevant to the project.
Which device does it support?
Identify the model, revision, configuration, sample and test method referenced by the record.
DOCUMENT GROUPS
What may need review?
Manufacturer and quality system
Legal manufacturer, applicable facility and quality-system certificate scope.
Platform and testing
Specifications, drawings, sample records, methods and results for the named device basis.
Traceability and change
Revision history, sample identity, approved changes and the records used by the project.
Commercial and export roles
Quotation, contract, payment, shipping, export and complaint responsibilities.
Document availability depends on the platform, manufacturer, project stage and confidentiality terms.
STANDARDS AND MARKET CONTEXT
Use each reference within its stated scope
The final device classification and market route depend on intended use, product configuration, labeling, target market and the parties responsible for the finished product.
ISO 11608-1:2022
Requirements and test methods for needle-based injection systems within its defined scope.
FDA injector guidance
Technical and scientific information expected for injectors intended for use with drugs or biological products.
FDA combination product definitions
Combination type and proposed labeling affect the regulatory analysis.
MDCG 2021-6 Rev. 1
European Union context for devices intended to administer medicinal products.
These links provide general reference material. Product-specific classification, validation and market access require formal review by the responsible organizations and qualified specialists.
Public information
Approved product statements, public certificates and redacted documents may be shared when the responsible party permits it.
Controlled information
Detailed drawings, validation records and customer data require an agreed purpose, NDA and transfer method.
Which documents does your team need to review?
Name the device route, target market, project stage and the decision the documents should support.