Improving quality for medical products and equipment will significantly bring down costs for their manufacturers. As the medical device industry is consistently growing and innovating, quality management is becoming a complex challenge for the companies. A quality management system (QMS) is an underlying need for every company to ensure their devices are effective and reliable for clinical applications. Many achieve ISO 13485 certification, a distinctive standard for quality management in the medical device industry which specifies regulations for designing, developing as well as the distribution process of medical products.Most experts claim that an explicit QMS having compliance with an eminent standard is the key for medical manufacturers to cut their overall costs. A significant portion of their costs are quality-related such as revenue losses due to delivery of poor or faulty devices, costs incurred in R&D (research and development) to improve quality and fines for medical safety noncompliance.However, that is just the tip of the iceberg.

There are many forms of costs accounted for maintaining quality and preventing any quality issues in medical devices. Here are they explained. Direct Costs of a QMSA significant cost is related to implementation of a strong QMS that will administer or control end-to-end aspects of production of devices. Mostly it includes the direct costs related to implementing ISO 13485 standard for their QMS. Costs involved include hiring of quality assurance consultants, getting gap analysis done, allocating resources for QMS implementation, carrying internal audits and so on. Medical manufacturers also need to engage quality personnel or special operations staff who will assess everything, from raw materials and inputs to packaging methods and storage conditions. Thus, all these involve certain costs known as direct costs for quality management.Costs for Poor Quality Products

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