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Medical Device and Restricted Hazardous Substances

  1. Testing: Either on-site or XRF testing and/or lab phthalate solvent extraction testing is done to determine values of the ten restricted RoHS substances.
  2. Process Audit: Inspect all applicable manufacturing processes used towards RoHS compliance on-site.
  3. Documentation Review: Review the Bill of Materials, Technical File, assembly drawings, materials declarations, test reports, and conformance/compliance certificates from all suppliers. The Technical File must contain the following:
    • General product description and design structure information
    • Risk assessment of materials, parts and subassemblies
    • Conformity information on materials, parts, and subassemblies
    • Manufacturing documentation and records
    • Harmonized standards, specifications, and conformity procedures
  4. Certification Statement: After a successful audit, a RoHS Certificate of Compliance (also known as a Certificate of Conformity or Declaration of Conformity) is issued.