medical device consulting Tag

Posted By: Stephanie Bouzounis, Senior Communications Specialist The deadline for the ISO 13485:2016 transition is fast approaching. In less than a year from now, changes will have to be made in order for companies to keep their certifications. Background The International Organization for Standardization (ISO) is a non-governmental entity...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The European Union (EU) published a new Medical Device Regulation in May 2017, giving manufacturers three years before full implementation in 2020. There are several changes in this new regulation. In a whitepaper by BSI titled, “Planning for implementation of the...

Posted By: Stephanie Bouzounis, Senior Communications Specialist Medical devices – like we mentioned in last week’s blog – fall into one of three classes: Class I, Class II, and Class III. Class I devices are low risk, and include over-the-counter items found at a pharmacy such as...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The 510(k) Process In alignment with FDA’s overall vision to improve various processes, there will be updates to the 510(k) process this year. Before the updates are mentioned, a background of this necessary process for medical device manufacturers must be understood. Background Under...

Posted By: Stephanie Bouzounis, Senior Communications Specialist Medical device manufacturers have much to think about when it comes to registering a product internationally. Different regions and countries have different standards for registration. With the impending divorce of the U.K. from the European Union, there are even more...

Posted By: Stephanie Bouzounis, Senior Communications Specialist February is American Heart Month, according to the American Heart Association. One of the aims of this federally designated month is to raise awareness about cardiovascular disease. The National Institutes of Health’s Heart, Lung, and Blood Institute (NHLBI) has created...

Posted By: Stephanie Bouzounis, Senior Communications Specialist 3D printing appears to be a novel technology in popular culture, but it has been around for over three decades. What is novel, however, is its prevalence in modern medicine. What is 3D printing? The ideological inception of 3D printing came...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The first month of 2018 is in the books, and for the Medical Device industry the outlook appears positive. The first big news item is the Medical Device tax. At the start of the year, it was initially reported by...