Certification & Documentation

iso 90001 logoMTD can supply Documentation packages to meet FDA and Regulatory requirements for both Medical Device and Pharmaceutical applications.

Medical Device

MTD is approved supplier for FS209E/ISO 14644-1 Class 1 cleanroom equipment.

Pharma Applications

All equipment supplied by MTD is supported with full traceability as part of the Project sign off documentation pack.
Standard certs include 3.1 material traceability cert + COC for elastomers.

Additional certification can include:

  • 3.1 Cert for Elastomers
  • Ra Surface finish Cert
  • Electro-polish cert
  • FDA Cert
  • USP Class 6
  • BSE/TSE Declaration
  • Degrease + passivation cert
  • GA Drawings