When it comes to testing, the most significant difference between CSV and CSA is that CSV focuses on a “test everything” approach, while CSA encourages us to use critical thinking to test more effectively. The following article outlines how companies can identify the appropriate degree of testing rigor for risk-based CSA validation to ensure the least burdensome approach.
Veeva has launched a new tool to help MedTech developers identify and engage with healthcare experts and key opinion leaders.
The FDA is requesting feedback on three new draft guidances related to clinical trials, including how they should be applied to increasingly diverse trial types and data sources.
A Venture Capitalist recently joked that to fund a startup, all one must do is choose a URL that ends in ‘.ai’. Although he was not serious, it was an acknowledgment that companies pursuing AI are getting much attention, and there is a fear of missing out (FOMO) in the investment community if one of…
Medtech companies can receive up to $300,000 for the adoption of advanced manufacturing technologies through the MDIC Advanced Manufacturing Clearing House. The program is designed to speed adoption and provide guidance for industry and the FDA on the most beneficial applications of advanced technologies.
At Device Talks Boston in May, Ronald Kurz, Sr. Director and GM at Canon Virginia, Kathryn Unger, Sr. Mgr. of Global ESG Communications at Boston Scientific, and David Ettl, COO at Gradian Health System, addressed the question, how can we make medical products sustainable?
An adhesive developer explains why skin is so challenging to adhere to, why it’s never too early to explore skin-adhesive options for your wearable device, and recent milestones in stick-to-skin adhesive longevity.
Smart hospitals are revolutionizing health care with the help of AI, IoT and robotics. Following are the latest technology and data analytics tools and trends that are helping these hospitals of the future provide safer, more personalized care.
Regulatory requirements for computer systems validation (CSV) have long been in place, but their compliance requires considerable time and resources. In the life sciences industry, traditional validation processes add to project timelines and costs, affecting time to market and preventing the deployment of newer versions of software. In addition to improving accuracy and coverage, automated CSV processes can create the same artifacts as manual execution and expedite the upgrade timeline.
There are several tactical approaches to design that can help medtech manufacturers inspire patient confidence in their products and ensure proper usage. Following are three ways you can help ease the burden of delivering and receiving quality care through product design.
