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.
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 In general, FDA approval is not withdrawn from a device so long as no material changes are made to its design or intended purpose.
The medical device industry represents a tremendous business opportunity for innovative firms. Part of the reason is demographics. In 2016, the National Institutes of Health reported that the world’s older population was growing at an “unprecedented” rate.
The medical device industry is one of the most heavily scrutinized and regulation-driven in the world. Regulatory challenges expand beyond the most sophisticated markets: Although the U.S. accounts for about 40% of the global market and Europe about 30%, high quality standards prevail in smaller blocs and nations as well.
Healthcare sector stakeholders are unlikely to change the way they operate to accommodate your new medical product unless it benefits patients and professionals alike. Similarly, your product must be future proof.
So, what steps can you take to make sure your medical product design provides value to stakeholders, both in the present day and the future?