regulatory systems

Include a REGULATORY SYSTEMS review during the concept through materials design stage to assure that the material meets all regulatory requirements in the target region.

REGULATORY SYSTEMS should be reviewed to ensure the product is truly compliant. Regulations can differ significantly by region and application. Even though a product might be formulated with quality materials, it might not be suitable for sale under all conditions. Expert consultation will lend peace of mind that each component meets the applicable regulatory standard.

TIMING
REGULATORY SYSTEMS should be reviewed during the initial design development phase.

process
  • Identify components for regulatory consideration
  • Review Global Harmonized System (GHS)
  • Review regional regulatory standards where applicable:
    • US: Prop 65 (CA), heavy metal, conflict minerals, etc.
    • EU: Registration, Evaluation, Authorization and Restriction of Chemical Substances (REACH), Restriction of Hazardous Substances (RoHS)
    • Rest of the world: understanding of the local compliance needed
  • Review application specific regulatory standard
    • Food contact U.S. Food and Drug Administration (FDA)
    • ISO10993, USP Class V or VI
    • (American Society for Testing Materials) ASTM D6400
  • Draft and review Product Regulatory Datasheet (PRD)
  • Review claims to make
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