Meeting US and European supplier control requirements.
Medical device manufacturers operating under European quality system requirements are sometimes surprised to learn that their supplier control procedures do not fully meet United States (US) requirements. This article discusses important differences between US and European requirements for controlling suppliers.
Donawa
Maria
M
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D019983:Guideline Adherence / Q000331:legislation & jurisprudence* / Q000592:standards*; D017408:Guidelines as Topic; D040541:Marketing / Q000331:legislation & jurisprudence* / Q000592:standards*; D011358:Product Surveillance, Postmarketing / Q000592:standards*; D014481:United States