What are the regulations for medical device calibration?
An example of an AI chatbot conversation about medical device calibration regulations.
What are the regulations for medical device calibration?
Medical device calibration regulations vary by country, but generally, they ensure devices are accurate and safe. In the U.S., the FDA oversees these regulations.
What specific standards should I be aware of?
Key standards include ISO 13485 for quality management systems and ISO 17025 for testing and calibration laboratories.
How often should calibration be performed?
Calibration frequency depends on the device and manufacturer guidelines, but it's typically recommended at least annually.
Are there penalties for non-compliance?
Yes, non-compliance can lead to fines, product recalls, and even legal action, depending on the severity of the violation.
Can you help me find resources for compliance?
Sure! I can provide links to FDA guidelines and ISO standards for medical device calibration.
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