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ISO 13485 Compliance

Medical device manufacturing faces major challenges with innovating and delivering new products to market in a highly-regulated environment. Companies must comply with ISO 13485, demonstrating they have a quality management system equipped to consistently meet customer requirements and regulatory mandates in the context of medical devices and related services.

Quality and compliance requirements are not new to medical device manufacturing. However, in recent years, regulatory requirements have tightened and become more challenging to manage across the board. Keeping up with ISO 13485 compliance requires modern, forward-looking technologies and strategies. Unfortunately, many companies are falling short of delivering this.

Sticking with the status quo in medical device manufacturing—relying on outdated spreadsheet-based and paper-based systems—is a risky approach in any highly-regulated industry. Inefficiencies, added costs, and negative impacts to productivity aside, managing ISO 13485 with legacy solutions is not a viable business strategy. Medical device manufacturers require solutions as agile as their operations.

Managing ISO 13485 Compliance with IQS

IQS delivers integrated quality management and compliance solutions engineered to transform the way manufacturers manage the ISO 13485 standard.

Quality management systems must be flexible enough to satisfy all requisite compliance challenges, while enabling a proactive approach to quality and compliance. IQS software provides a single hub for managing compliance across the enterprise, while also employing controls and tools to proactively identify which components of ISO 13485-compliant systems need improvement.

ISO 13485 regulations contain a variety of exclusions which must be identified in order to remain compliant with the latest standards. As such, quality management systems must have the ability to coordinate all applicable sections of ISO 13485—particularly clause 7 of ISO 13485. The IQS enterprise software solution is built to overcome challenges such as this.

The constantly evolving domestic and international regulations related to ISO 13485 make compliance much more difficult to manage at a low cost. IQS centralizes the management of all ISO 13485 requirements, providing your organization with the up-to-date systems, tools, and data needed to drive innovation and production without the burdens of compliance.

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