Why Does ISO 13485 Certification Matter?

Why Does ISO 13485 Certification Matter?

In today’s medical device industry, it is becoming essential to select product development partners that have ISO 13485 certification. In fact, more and more medical device manufacturers are requiring their suppliers to be ISO 13485 certified.

One cause for this shift is the result of a recent recommendation by the European Commission (EC) to mandate unannounced audits of medical device manufacturers by Notified Bodies. The EC’s recommendation is to require unannounced audits at least once every three years and extends to encompass not only the medical device manufacturer, but also their critical suppliers -- including design partners, such as Stratos.

Knowing your critical suppliers will be prepared to support unannounced audits is just one reason to require ISO 13485 certification; however, there are many other benefits of working with certified suppliers.

1. Peace of mind. When a product development firm is ISO 13485 certified, you can be confident that appropriate processes are in place to develop products which meet EU and FDA requirements in support of your market strategy.  A certified quality management system (QMS) has been audited by a third party and provided evidence of consistent results in product development and throughout all QMS processes.

At Stratos, we have taken great effort to develop our QMS to provide flexibility and adaptability needed to successfully support a variety of products and expectations for clients ranging from start-up to multi-national medical device companies across many different market segments. We know the medical device regulatory environment can be a challenge to navigate. Our goal in achieving ISO 13485 certification is to bring peace of mind to our clients.

2. External Review. This introduction of unannounced audits creates an additional burden on medical device manufacturers to ensure their design partners are ready to support and succeed in unannounced audits. A development partner that is ISO 13485 certified is subject to annual assessments by their certification body which continues to monitor the performance and compliance of that partner’s QMS.  This degree of accountability can significantly reduce the element of uncertainty or risk assumed by the manufacturer since a certified design partner has already demonstrated the ability to comply with applicable requirements.

3. Meeting Client Requirements. ISO 13485 is focused on more than simple compliance to a well-defined and executed product realization process. It emphasizes understanding client requirements throughout the process and staying focused on what is needed to get to market. One example is formalized processes around contracts and client satisfaction which facilitate communication in the beginning of the engagement and continues throughout product realization to ensure client requirements are being met.

Stratos has a long history of developing products within a regulated environment for the medical and aerospace industries. ISO 13485 certification was a natural next step. Selecting a design partner with ISO 13485 certification reduces risk and allows medical device companies to focus resources and time on other elements critical to bringing products to market.


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