2nd of Five blogs covering each of the listed steps in the medical device process

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.


1st of Five blogs covering each of the listed steps in the medical device process

post2ISO 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.


Medical device market overview

medical-Device-Overview.jpgThe 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.


What is the ISO organization and why does its standard matter?

iso-blog-post.jpgThe 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.


Will your medical product design stand the test of time ?

Medical Product DevelopmentHealthcare 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?