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Safety...

Of course, safety issues cover mechanical, material, electrical hazards, etc. You must establish the design is safe and the design was tested for safety.

If the equipment fails, that may not be unsafe, that is a failure. But, if the equipment renders a false diagnosis or false treatment that is intolerable- that is unsafe!

The FDA also wants the materials that contact the patient is tested to meet primary skin irritation and cytotxicity tests.

On most new complex devices the FDA expects to see a reasonable FMEA Failure Modes and Effects Analysis or risk analysis.

copyright by Compliance Consultants, Stamford, CT USA, September 2001