MD&M East

Cytotoxicity Testing for Medical Devices: A Guide to Compliance & Best Practices

Medical device manufacturers use cytotoxicity testing to help prove that devices that come into contact with the human body are biocompatible. Testing results are critical for gaining market access, ...
MD&M East

Considerations for the Biocompatibility Evaluation of Medical Devices

FDA uses a range of biocompatibility test data to evaluate medical devices before clearing or approving them for marketing. The growing use of FDA-recognized consensus standards facilitates this ...
usace.army.mil

MTEAC conducts operational testing of the multiple devices

JOINT BASE LEWIS-MCCHORD, WA–The U.S. Army Medical Test and Evaluation Activity (MTEAC), in collaboration with the U.S. Army Medical Materiel Development Activity (USAMMDA) Program Executive Office ...
Washington City Paper

Digital Twins in Medical Devices Testing and Registration

As ‍ ‌‍ ‍‌ ‍ ‌‍ ‍‌ data-driven innovation profoundly changes every industry, the healthcare sector is also affected. Digital twins – virtual copies of physical devices – are essentially changing the ...
Morningstar

Hohenstein Medical Earns GLP Certification for Medical Device Testing

Good Laboratory Practice certification expands company's ability to support medical device manufacturers in meeting the complex demands of international regulatory frameworks "Our customers are ...
Morningstar

Eurofins Medical Device Services Launches first GMP PFAS Screening and Testing Solutions for 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 ...
MobiHealthNews

FDA: No inspecting labs testing medical devices

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 ...
Business Wire

atsec AB first IEEE 2621 Accredited Medical Device Testing Facility

AUSTIN, Texas--(BUSINESS WIRE)--atsec AB Stockholm, Sweden is thrilled to announce: We are the first IEEE Authorized Testing Facility! We've officially been approved as an IEEE Authorized Testing ...
AZOM

How Can Mechanical Testing for Medical Devices Advance the Treatment of Diabetes?

In this interview, Instron's Landon Goldfarb discusses the importance of mechanical testing for medical devices used in diabetes care and treatment. How has the treatment of diabetes changed over the ...
FierceBiotech

WuXi AppTec sells US medical device testing business to NAMSA

WuXi AppTec is parting ways with its U.S. medical device testing business, selling its two stateside locations to the Ohio-based regulatory consulting firm NAMSA. The deal includes facilities in ...