The Importance of ISO 13485 Certification for JAKTOOL and Its MedTech Customers

November 12th, 2024 in

Achieving ISO 13485 certification is a significant milestone for JAKTOOL, especially as the company continues to serve its growing base of MedTech customers. ISO 13485 is an internationally recognized standard specific to the medical device industry, ensuring the highest level of quality management for product development, manufacturing, and distribution. For a company like JAKTOOL, which has traditionally focused on prototype development, this certification opens new opportunities in delivering fully realized medical products to market.

This blog will explore the value of ISO 13485 certification, how it enhances JAKTOOL’s offerings, and the direct benefits it brings to our MedTech customers.

 

What is ISO 13485?

ISO 13485 is a globally recognized quality management system (QMS) standard for the design and manufacture of medical devices. Unlike ISO 9001, which applies to general industries, ISO 13485 is specifically tailored for the stringent regulatory requirements of the healthcare sector. It emphasizes risk management, documentation, and quality assurance throughout the product life cycle, from initial design to final production.

By achieving this certification, companies like JAKTOOL demonstrate their ability to consistently meet regulatory requirements and ensure that medical devices are safe and effective for end users.

 

Why ISO 13485 Certification Matters for JAKTOOL

JAKTOOL’s ISO 13485 accreditation marks a significant step forward for our quality management system. Historically, we have focused on prototyping, transitioning innovative ideas into functional products. However, with this certification, we can now take those early-stage designs through the entire engineering lifecycle, all the way to market-ready products.

As Cristy Richards, JAKTOOL’s President and MedTech advocate explained in a recent discussion, ISO 13485 enables JAKTOOL to “de-risk the customers’ product development and product launch journey.” This ensures that when our customers partner with us, they are working with a company that is not only knowledgeable about the development process but also capable of delivering fully compliant, high-quality medical devices ready for market.

 

How JAKTOOL Achieved ISO 13485

Obtaining ISO 13485 certification was a team effort, led by Operations Manager Kaitlyn Neroladakis. JAKTOOL already maintained a strong QMS under ISO 9001:2015, but ISO 13485 demanded a more rigorous approach to documentation, risk analysis, and design verification. Neroladakis and the operations team conducted a thorough gap analysis, identifying areas where additional controls and documentation were necessary to meet the new standard.

For instance, ISO 13485 places a greater emphasis on formalizing the design process. This means documenting user needs, design inputs, and how these translate into measurable design outputs. Verifications and validations ensure that the final product meets the required specifications, reducing the likelihood of costly and time-consuming iterations.

 

Benefits of ISO 13485 for JAKTOOL Customers

Achieving ISO 13485 provides several key benefits to our MedTech customers, making JAKTOOL an even more valuable partner in product development.

  • 1. Accelerated Time-to-Market:

    • The structured procedures and risk management protocols established by ISO 13485 help streamline product development, allowing JAKTOOL to avoid common pitfalls that often slow down the process. By addressing potential design and manufacturing issues early on, we can help our clients bring products to market faster, reducing the time spent on revisions and corrections.

  • 2. Enhanced Product Quality and Safety:

    • ISO 13485 ensures that every medical device we develop and manufacture meets rigorous safety and quality standards. This means our customers can have full confidence in the products we deliver, knowing they are compliant with regulatory expectations and built to the highest industry standards.

  • 3. Easier Regulatory Approval:

    • Medical devices are heavily regulated, and obtaining FDA or other regulatory approvals can be a complex, time-consuming process. However, by adhering to ISO 13485, JAKTOOL ensures that the necessary quality systems are in place, making it easier for customers to present their products to regulatory bodies and gain approval. As Christy Richards noted, our compliance with these standards can significantly assist customers in navigating the regulatory landscape.

  • 4. A Full-Service Development Partner:

    • With ISO 13485 certification, JAKTOOL can now take on the role of a full-service development partner. From initial product concept to final production, we support our clients through every step of the design and manufacturing process. Whether customers need assistance with product documentation for regulatory submissions or ongoing manufacturing support, JAKTOOL is equipped to handle the entire journey.

 

Expanding Opportunities for MedTech Innovation

JAKTOOL’s commitment to continuous improvement is not limited to achieving certifications. We constantly seek new ways to enhance our quality management systems and improve our processes. By fostering a culture of innovation and excellence, we empower our customers to bring groundbreaking medical devices to market more efficiently and effectively.

In the future, we are prepared to pursue additional certifications, such as AS9100, for aerospace customers as customer needs evolve. This flexibility allows us to grow alongside our clients, ensuring that we continue to meet their quality and regulatory requirements as they scale their operations.

 

Conclusion

ISO 13485 certification is a critical milestone in JAKTOOL’s evolution as a leading product development partner for the MedTech industry. By adhering to this stringent quality management standard, we not only improve our internal processes but also deliver significant value to our customers. From faster time-to-market to enhanced product safety and easier regulatory approvals, ISO 13485 positions JAKTOOL as the ideal partner for medical device innovation.

For MedTech companies looking for a development partner that can take their ideas from concept to the consumer market, JAKTOOL’s ISO 13485 certification offers the confidence and expertise needed to succeed.

 

WHAT IS THE VISION VAULT?

The JAKTOOL Vision Vault is a space for us to expand on the passions that drive innovation and growth at our company. On this blog, we’ll take deeper dives into industry news and our expertise and highlight the leaders we have under our own roof through featured blogs. Follow along for updates throughout the month and recaps on new episodes of JAKTALK, our biweekly podcast hosted by our founder, COO, chairman, and visionary, Jeff Kinsberg.

 

This article is based on conversations had in JAKTALK episode #14. You can watch the full episode on YouTube below: