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Is your equipment validated?

Answered by: 

Mike.Barrilli

Answer

Pulse took guidance from industrial regulations like 21 CFR 820.75, Medical Device Directive 93/42/EEC, ISO 13485 7.5.2, ISO 9000 3.8.5/3.8.6, Global Harmonization Task Force SG3/N99-10, and ISO 14971 to develop a Validation Master Plan for qualification of core process equipment. Pulse develops and executes IQ/OQ/PQ on all core equipment. Pulse also performs product validation for customers based on customer specifications and acceptance criteria.