Is Risk Reduction Necessary?

Performing a Risk Evaluation

After completing your Risk Analysis, the next step is to perform a Risk Evaluation.  According to ISO 14971, “For each identified hazardous situation, the manufacturer shall decide, using the criteria defined in the risk management plan, if risk reduction is required…The results of this risk evaluation shall be recorded in the Risk Management File.” Risk…

Complaint Files

A requirement of ISO 9001, ISO 13485 and the FDA’s 21 CFR 820 is in regards to complaint files.  According to 21 CFR 820, a complaint is defined as “any written, electronic, or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is…