medical-device

Medical device manufacturers who want to sell their devices on the EU market must draft and maintain a clinical evaluation report compliant with the European Medical Device Regulation (MDR; 2017/745). The clinical evaluation report is a critical step for CE marking of medical devices and during the lifetime of the device - it must be updated continuously. While the EU MDR does describe clinical e…

Software as a Medical Device (SaMD) is “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device,” accord to the International Medical Device Regulators Forum. In other words, SaMD is a stand-alone computer program to resolve specific tasks in the healthcare industry. SaMDs facilitate healthcare providers’ work becau…

EMEA Office Louizalaan 489 1050 Brussels Belgium 00 : 03 : 15 From an academic idea to launching 00 : 14 : 00 Challenges in Sales 00 : 21 : 50 Getting ready for ISO 13485 00 : 28 : 20 First large contracts 00 : 44 : 30 From an R&D company to a Sales Company and OraSure subsidiary Watch this exciting journey from academic research to acquisition and beyond with Vanessa Vankerckhoven, CEO and co-fo…

Laurent Leksell, PhD, MBA, founded Elekta AB to commercialize his and his father’s – Lars Leksell’s – inventions in stereotactic surgery and radiosurgery.

Software as a Medical Device (SaMD) is a groundbreaking advancement in the healthcare industry, transforming the way medical care is delivered and managed. First developed in its earliest forms in the 1980s, this category of software operates independently to perform medical functions from diagnostics, patient monitoring, and image processors to artificial intelligence (AI) and deep learning neur…

Incubators and accelerators are programs designed to help start-up companies gain traction. Incubators generally focus on very early companies or entrepreneurs at the idea stage, while accelerators are designed for more advanced companies with products in preclinical or clinical trials.  The programs come in many different flavors. Incubator and accelerator programs can be non-profit or ...

Shawn P. Fojtik (BS ’85, advertising), CEO of Control Medical Technology and Distal Access, has more than 150 pending and issued medical device patents with over 1 million patients safely treated in cardiovascular, women’s health, cardiac electrophysiology, surgery, interventional oncology, and emergency medicine.  Fojtik’s previous work experience includes sales, marketing, product development, …

Using CFD to Evaluate Medication Delivery TotalSim US Evaluates Medical Device The Situation: Patients need to be put on a ventilator for many reasons including while under general anesthesia during surgery or respiratory distress. Some patients will have problems that result in constriction of bronchi and bronchioles which needs to be treated by administering bronchodilators such as Albuterol an…

US regulators are teaming up with medical device companies and non-profit organizations in an effort to advance better and safer tools for evaluating the safety, quality and efficacy of medical technologies. Read more Continue reading →