Last month, Product Creation Studio proudly announced that we added ISO 13485:2016 Certification to our lineup of expertise. This certification is specific to the design and development of medical devices and represents the highest standard of quality a company can achieve.

To the client’s benefit, the focus on developing robust product requirements, establishing risk management practices to uncover any hidden safety issues, and a strong focus on user interaction ensure the resulting device can be used safely and as intended.

A strategic tool for any size of business, iso.org notes that ISO standards can reduce costs, satisfy consumers, open access to new markets and improve product performance. While it may be hard to prove a direct correlation between an ISO-certified quality system and performance, these standards have been proven to enhance product efficiency and marketability.

For example, regulators from various countries, such as Canada, Australia, EU and Japan have adopted ISO 13485 into their own regulatory systems. In order for a device to be sold in Canada, Health Canada (the Canadian Medical Device Regulations Program) requires evidence that medical devices be produced under a quality system. In addition, in the U.S. these standards can also be used as evidence of compliance with the FDA’s Quality System Regulation.

What are the benefits of ISO 13485 certification to product owners?

1. Sound and complete product requirements.

What the standards require: Businesses are required to create process standards that define the product’s requirements in a complete, unambiguous and appropriate manner, as well as address the intended use of the device. Defining these requirements should include participation from the product owner, as well as the industrial design and engineering teams. 

What this means: For each product, the team records all information that informs design and engineering decisions in a succinct and systematic way. These requirements capture more than just features, they include the device’s function, performance, and the interfaces between component and software.

Problem avoided: It’s very expensive to learn a key feature of your device is missing once you’ve committed a design to a manufacture. By tracking and documenting each feature, performance, interface relationship and more, you are forced to fully consider each aspect of your product.

2.  A defined process for effective risk analysis.

What the standards require: Safety standards require you to define a strict process for risk management activities in product realization.

What this means: Risk management activities include the identification, assessment and prioritization of risks, followed by the potential hazards of using the medical device and are intended to prevent harm to the user.

Problem avoided: It’s very costly to discover that your device (once it’s already in use) causes harm to the user. This can result in a product recall or liability cases.

3.  A user-centered approach to product development.

What the standards require: Standards require you to define a process for the [RM1] application of usability in medical devices. This process can be incorporated into device design, development and risk management processes.

What this means: A user-centered approach to product development ensures the product is safe, effective and easy to use. Defining use scenarios, task flow, and intended users will help guide design decisions and ultimately, maximize user adoption. To identify possible risks early and often, error analysis and use case studies are required to be conducted at each key development stage.

Problem avoided: Incorporating human factors into your device design early on will save product owners from investing massive amounts of money on the design and build of a product that either doesn’t meet the user’s needs or could harm them during use (which also goes hand-in-hand with proper risk analysis).

4. The product development process is subject to external quality reviews.

What the standards require: Recently released into the regulatory system, is the implementation of routine unannounced audits.

What this means: As an ISO-certified development partner, we are subject to routine visits from our standards company to monitor the performance and compliance of our quality management system.

Problem avoided: This degree of accountability greatly reduces the risk and uncertainty assumed by the design, engineering and manufacturing partners or groups.

Conclusion

Product Creation Studio supports clients in the medical device industry by designing and engineering products that are fully compliant with FDA regulations, resolving any concerns regarding product safety and reliability. Our portfolio includes work with innovative medical devices, showcases end-to-end support through a product’s development life cycle, and the optimization of existing products to create opportunities for our clients in adjacent market segments.

At Product Creation Studio, we’re proud to be the sole ISO 13485-certified product development firm in the Pacific Northwest. This certification continues our tradition of striving towards the highest standard of product excellence.

If you’re not familiar with ISO 13485, you can check out our blog post ISO 13485:2016 Certification for a quick overview on what it is and how it fits into our PCS+ Quality System here at Product Creation Studio.