International Biophysics is an FDA-registered and ISO 13485 certified medical device manufacturer. We are a 26-year-old company that manufactures, and markets medical devices across the globe.
What that means, in terms of quality, for products such as the AffloVest, is that every product goes through a rigorous design and manufacturing process, inspection process, periodic audits by the FDA and other regulatory bodies to verify compliance with all the various regulations.
When we look at new technologies and applications, we really focus on what we feel are disruptive technologies and not minor incremental improvements. In the example of the AffloVest, we see a product category that doesn’t have a lot of evolution over time, and we really want to bring something that really disrupts the market and results ultimately in improving patient care for the entire population that uses these types of products.