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Medical Device


The nature of medical device manufacturing is closely related to patient health and well-being. As a result, medical device companies are required to comply with strict regulations such as ISO 13485. As is the case with other industries that serve the public, the slightest nonconformance in a medical device’s quality could have catastrophic impacts to not only the user of the product but also a company’s reputation and long-term performance.

Manufacturers have been able to maintain their momentum with homegrown or point solutions designed to satisfy compliance requirements for mandates and standards such as ISO 13485 and FDA 21 CFR Part 11. This, however, is far from a sustainable long-term strategy.

Companies competing in life sciences industries thrive on their ability to deliver new products to market without being slowed down by regulatory compliance. Effectively moving from the ideation phase through design, production, and delivery requires uninhibited communication and collaboration across departments. Leading manufacturers are deploying enterprise quality management software as their quality and compliance hub, using it as an intermediary between existing product development and manufacturing operations solutions.


IQS has a long history of serving the medical device industry. Designed to accelerate new product development and introduction by building quality and compliance into the product lifecycle, IQS enterprise quality management software is the leading choice for medical device manufacturers.

The integrated QMS Software solution has capabilities such as mobile auditsdocument controltraining, and supplier quality, as well as modules like risk management and customer complaints to promote a closed-loop quality management ecosystem.

IQS’s modern approach to end-to-end quality management and compliance enables medical device manufacturers to focus on innovation and growth. Learn how IQS takes a platform approach to ISO 13485 compliance.


IQS yields actionable insight into performance, cost of quality and risk-related metrics including real-time visibility on supplier quality, production and customer satisfaction. All things to help you maintain a competitive advantage. Here is a sampling of IQS customers in this industry who trust IQS for their quality management and compliance software needs.

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