Final delivery and validation of a medical device at a customer site is a significant achievement for all.
It often takes years for an innovative medical device to go from concept to realization. For the device manufacturer, production and distribution are further steps in a long, complex journey. Installation at the customer site is the last phase before control of the device is transferred.
When does a company’s responsibility for its medical devices end?
ISO 13485 is a global standard for quality management and assurance in medical devices. In previous posts, we have discussed the basis of the standard and its comprehensive nature. Because of its rigorous detail, it empowers organizations to adapt to the many serious challenges of preparing their devices for commercialization and executing according to the highest regulatory expectations.
ISO 13485 is the leading global standard in medical device quality management. The fact that it is comprehensive is a key reason it stands above all other attempts to synthesize expertise on this complex subject. It offers crucial guidance through each phase of product design, management, distribution, and installation calibrated to achieve success in a regulation-driven global market.
In the U.S., the medical device industry represents a $140 billion market – about 40% of the global total. Over 80% of U.S. medical device companies employ fewer than 50 people, demonstrating the huge opportunity for small enterprises alongside established players.
After a medical device passes the strict scrutiny of the Food and Drug Administration, it is cleared for marketing in the United States. In general, FDA approval is not withdrawn from a device so long as no material changes are made to its design or intended purpose.
Medical device innovations require world-class expertise. No matter whether a company has a dozen or a thousand researchers, however, their involvement is one part of a complex system. Many organizations and agencies are involved in each device’s journey to the market.
Regulatory compliance is essential to successfully developing, deploying, and commercializing a medical device. A single example of noncompliance, if it is egregious enough, may cause the Food and Drug Administration to terminate your ability to market a device in the United States.