Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820.
Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.”
This two day interactive course on FDA regulations for medical devices will:
This seminar course will be beneficial for the following personnel in medical device manufacturing companies and in medical device supply chain:
Note: Use coupon code < NB5SQH8N > and get 10% off on registration.
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