Why MindFlow Design’s ISO 13485:2016 certification matters

In September, MindFlow Design received ISO 13485/2016 certification for its work in medical device design and development. Based on a third-party audit, the company’s quality management system met the criteria set by the International Organization for Standardization. Businesses involved in medical product development must constantly prioritize regulatory compliance, taking into account the massive implications that international standards can have for long-term growth.

Mindflow Design’s certification is the latest sign of its dedication to staying in step with the global demands of the medical device industry and the requirements of its customers. Fulfilling current ISO standards is a crucial part of developing and engineering the next generation of medical products. Robust quality controls facilitate processes that emphasize usability in healthcare, human factors engineering and advanced medical user experience design.

Medical product design and quality systems

The ISO’s quality systems standards ensure that medical devices undergo a rigorous, well-documented design process for safely meeting user needs. Design controls promote continuous improvements in an organization’s practices, all geared toward managing risk and bringing patients better results. By laying out the specific procedures, resources and deliverables that go into creating a product, a firm is able to comply with applicable regulations and successfully take a device to market.

While ISO standards are not laws themselves, compliance with these rules is an important step toward meeting the requirements in specific nations, especially for the European market. As of November, 2017, the ISO counted standards organizations from 162 countries in its membership, all drawing on the international guidelines to establish their rules. For instance, the U.S. Food and Drug Administration maintains its own quality systems regulations, but they are harmonized with ISO requirements.

Quality systems involve a variety of subsystems that must work together to produce safe, effective products on a consistent basis. According to FDA guidelines, the four major subsystems include:

• Management controls.
• Design controls.
• Production and process controls.
• Corrective and preventative actions.

When it comes to design controls, device makers are responsible for establishing a plan, identifying the inputs and anticipated outputs, and then verifying and validating the results. Clearly defining and applying these procedures are vital aspects of producing successful products.

Understanding ISO 13485/2016

The latest revision of ISO 13485 was published in March 2016, replacing the version that had been in place since 2003. A gradual rollout followed, with the organization recommending that all new certifications be based on the 2016 standards within two years and all existing certifications declared invalid within three years. The new version focused on expanding medical device quality management systems to play a major role at all points in a product’s lifecycle and the supply chain.

According to the Regulatory Affairs Professionals Society, some of the most significant changes included:

• Incorporating more risk-based approaches.
• Linking with regulatory requirements for documentation.
• Harmonizing software validation requirements.
• Maintaining infrastructure for producing sterile medical devices.

MindFlow will undergo continuing audits every three years to maintain its ISO 13485/2016 certification. These reviews will also cover the requirements for ISO 9001:2015, a broader designation for quality management systems. This standard includes provisions for documentation, process interactions, resource management and improving the quality management system over time.

By staying in line with international standards for quality systems, organizations set the conditions for smooth product development. Regulatory expertise is an indispensable factor in creating medical devices that achieve reliable outcomes with minimal risk.