The contract research organization will launch an expanded ISO 18562 gas pathway testing program and ISO 10993-18 particulate ...
Devices used in laboratories, hospitals and similarly high-demand settings must remain consistently accurate to encourage trust in the parties using them for critical tasks. However, overheating can ...
Even though the FDA recently began an open dialog with the wireless medical device community over mHealth regulation, enforcement of federal quality regulations at labs that develop medical devices ...
Eurofins Medical Device Services North America, part of a global network of over 20 medical device testing laboratories and a leading medical device solutions partner, recently launcheda GMPPFAS ...
Laboratory-based design verification testing (DVT) of combination products and medical devices must be performed to demonstrate that the device meets the performance requirements that were set in the ...
The integration of artificial intelligence (AI) into the design of medical devices heralds a new era in healthcare—one where innovation meets precision to significantly enhance patient outcomes. This ...
U.S. and EU regulators require human factors and usability testing to bring a medical device to market. Virginia Lang, PhD, president and chief scientist at HirLan Inc., an engineering consultancy ...
STEMart, a US-based provider of comprehensive services for all phases of medical device development, has announced the availability of its robust In Vitro Micronucleus Test service to meet the ...