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We mentioned the animal testing briefly in the biocompatibility section, and completed the Animal Testing section. ------------------------------ William Coulston PMP, MS, RAC Director of Quality & Regulatory Affairs Rochal Technologies San Antonio TX United States ------------------------------

Anon, The process used could be an existing process like change control or it could be an independent process determined by your organization based on risks related to the supplier change's impact on safety or effectiveness. As a medical device manufacturer, we route supplier changes through our change ...

I agree with Anne completely. More communication is better than less. I think you should communicate your requirements to the Quality Department. The necessity depends on what you hope to do with the eQMS. Does regulatory want to iterate within the eQMS or does regulatory simply want to import documents ...

Colleagues, I am hoping to get your opinion on the upcoming reclassification of General and Plastic Surgery Devices specifically, classification of certain solid wound dressings; wound dressings formulated as a gel, creams, or ointment; and liquid wound washes. See Federal Register / Vol. 88, No. 229 ...

Anon, It also seems like part of the customer's supplier qualification process would need to assess whether the "subcontractor" can meet the customer's requirements related to a validated computer system(s). Specifically, any hardware or software used to automate any part of the device production process ...