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Single-Audit, UDI And Software International Harmonization Docs Finalized

The International Medical Device Regulators Forum issued four final guidance documents on an upcoming pilot that will allow companies to satisfy inspection requirements for four countries in one inspection, and separate documents on a global unique device identification program and standalone software.

Guidance documents on a four-for-one international facility inspections pilot program, as well as guidance on unique device identifiers and software were finalized Dec. 18 by the International Medical Device Regulators Forum.

The guidelines represent important progress for the two-year old harmonization body toward making the requirements that device companies

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