NCs in medical device industry

In the medical device manufacturing industry, non-conformance refers to any deviation from established quality standards and regulations.

Some common types of non-conformances in the medical device manufacturing industry include:

• Design NCs: These occur when a device or product is not designed to meet the required specifications, regulations or standards.
• Manufacturing NCs: These occur when the manufacturing process does not conform to the required specifications, regulations or standards.
• Material NCs: These occur when the raw materials used in the production of a medical device do not conform to the required specifications, regulations or standards.
• Labelling NCs: These occur when the labelling or packaging of a medical device does not conform to the required specifications, regulations or standards.
• Documentation NCs: These occur when the required documentation, such as procedures, work instructions, and records, do not conform to the required specifications, regulations or standards.
• Testing NCs: These occur when the testing or verification of a medical device does not conform to the required specifications, regulations or standards.
• Equipment NCs: These occur when the equipment used in the production of medical devices does not meet the required specifications, regulations or standards.
• Calibration NCs: These occur when the calibration of equipment or instruments used in the production of medical devices does not conform to the required specifications, regulations or standards.

It is important for companies in the medical device manufacturing industry to identify and address non-conformances promptly to ensure that products are safe, effective, and comply with regulatory requirements.

For more details on NCs in Investigation and Root Cause Analysis, stay tuned/visit for our next blog.