Latest in medical device software testing Software malfunctions pose several risks to medical devices and patients’ wellbeing. Inadequate software testing may cause the risk of disclosing patients’ confidential health information, thereby failing Health Insurance Portability and Accountability Act (HIPAA) ...
Using systems thinking throughout the life cycle of a device is essential as medical devices become more sophisticated. Timothy Bowe January 1, 2008 18 Min ReadSOFTWARE Illustration by ISTOCK PHOTO The effect of incomplete or insufficient testing of products is directly felt in the areas of produc...
Unless you have the right medical device testing and development tools to: Gain a competitive edge. Meet compliance every time. Automate manual processes. Test medical devices faster. What's the State of Medical Device Development? In our “State of Medical Device Development” surveys, hundreds ...
ISO 14971, Medical Devices – Application of Risk Management to Medical Devices IEC 62304, Medical Device Software – Software Life Cycle Processes Other healthcare industry testing services: Biocompatibility testing and evaluation of medical devices Reprocessing reusable medical devices Process control- ...
Have medical devices such as active implantable medical devices tested for market approval by cetecom advanced - EMC tests and more
Cardiovascular Device Testing Element specializes in a wide range of testing for cardiovascular devices, such as stents, grafts, occluders, catheters, heart valves and pacemaker leads. Read More Product Specific Regulatory Compliance RoadMap RegNav combines expert insights with AI software, giving ...
FDA Uses CodeSecure to Analyze Recalled Medical Devices Boston Scientific Streamlines Analysis of Medical Device Software CodeSonar Helps Harvard Apparatus Tackle the Medical Device Market Testwell CMT++ and Testwell CMTJavaCode Complexity Measurement Tool for C, C++, Java, and C#. ...
Patents and applications for testing medical devices Metered Dose Inhaler The metering valve, whose performance is assessed with this test, is a critical component of a finished metered-dose inhaler. Read more Needle Sharpness Determined by standard substrate penetration, this is an important characteris...
Electrical Medical Devices Testing Solutions Reach your target markets quickly and cost-effectively with electrical, electromagnetic compatibility (EMC), bluetooth and wireless testing, cybersecurity, software and mobile application testing and certification for your medical device. FDA ASCA Program The FDA'...
All medical devices have a very specific and very thorough set of testing requirements imposed by the U.S. Food and Drug Administration (FDA), the European Community, and other regulatory bodies. This testing is rigorous for two main reasons: * In many cases, medical equipment connects ...