Many device companies fail to realize how much money they could save (or even generate) by developing and implementing a
quality management system that adheres to ISO 13485. Although the standard is not designed to make every medical device
company equal in talent or ability, it is designed to help management understand how company processes correspond to ISO
13485, and why those processes work in the way that they do. In other words, the standard is designed to make the quality
system transparent for business and now between regulatory bodies (MDSAP).
Unclear or vague documentation is often what keeps company processes and ISO 13485 compliance at odds. Once
documentation presents a clear and deep understanding of how processes and standards fit together, and why they are designed
as they are, it becomes easier to spot errors, avoid costly regulatory sanctions and provide effective employee training.
Clear training and understandable SOPs enable employees to understand their assigned tasks, as well as any deviations or
nonconformance events they are responsible for reporting. The end result: confident employees who are more satisfied with
the company, and their role within it. When employees are satisfied and productive, deviations “bubble up” through the system
faster, and a positive financial impact is all but guaranteed.
According to Quality Digest magazine, there is more than one way to save money by adhering to ISO 13485 standards. “Having
a quality management system [based on ISO 13485 standards] at an early stage provides another advantage to these companies
[medical device companies]: quicker market access. Many regulatory organizations were involved in the development of this
standard. Therefore, requirements in regulatory laws such as the MDR share numerous similarities with ISO 13485. Hence, after
a simple update of their systems, these companies can quickly and cost-effectively seek regulatory approvals from a variety of
countries.”
The same article states “For medical device manufacturers, it is mission-critical to receive such certification [ISO 13485
certification] quickly. They invest in both research and development, and in the product’s sales and marketing plans. Particularly
in the medical device industry, the longer a product languishes in the review process, the less it returns to the manufacturer’s
bottom line.”15
Medical device companies can also save a significant amount of money by automating their quality processes, a concept which
will be expanded on in upcoming sections.
