Major financial risks
Medical device companies manufacture their products in a highly regulated market. Defective products can cost hundreds of thousands, if not millions, of dollars in fines, inspections and audits. That doesn’t even account for the indirect costs of losses in a shutdown, products pulled from the market and reputational damage.
The high cost of achieving certainty
Medical device products need to be assembled and packaged according to strict requirements. Design controls lower manufacturing risks and device histories deliver traceability for quality systems. But, how can you be 100% sure the correct product was assembled and have indisputable proof of conformance?
The human factor
And, let’s face it: mistakes happen. While highly effective quality control goes a long way to eliminate defective products and limit kiting errors, it only takes one to cause injury or death to a patient. The responsibilities of remediating any quality incident include recalls, field corrective measures and preventive actions.