Testing & Validation for medical devices

Testing means establishing whether a single result is correct. Validation means demonstrating that a process consistently delivers correct results. Medical technology needs both, and ISO 13485 draws the line sharply: wherever a result cannot be verified by subsequent inspection, the process must be validated — for sterilisation, sealing, welding, bonding, cleaning and injection moulding, that is the rule.

The range of services is correspondingly wide. It spans calibration of measuring equipment traceable to national standards, measurement system analysis and initial sample inspection, through to the major validations: sterilisation to ISO 17665, 11135 or 11137, packaging and sterile barrier systems to ISO 11607, cleaning and reprocessing, and biological evaluation to ISO 10993.

For buyers, one distinction is worth making that quotations often blur: whoever only measures delivers numbers. Whoever validates delivers a report that withstands an audit — with a plan, acceptance criteria, deviation handling and assessment. Ask for a sample report before you commission; the difference shows there faster than in any service description.