Compliance in Medical Device Development – IEC 62304, ISO 14971, IEC 60601 and more

Medical device development is increasingly reliant on software to enhance the functionality and maintenance of medical products. In the context of medical device development, software complexity equals risk. Therefore, increasingly stringent regulations and industry standards have been devised to stipulate thesafety, reliability and quality requirements. This article from Intland outlines how to achieve and prove compliance with several standards [...]

2016-01-14T06:39:50+00:0014th January, 2016|Blog, Thought Leadership|

Understanding IEC 62304 for Medical Device Compliance

IEC 62304 is the international standard that defines software development lifecycle requirements for medical device software. As software becomes an ever more important component of medical devices, compliance with standards has become essential. This article from ISS outlines how IEC 62304 standard is being used for medical device compliance. Read More Learn more about T&VS [...]

2015-12-29T05:54:04+00:0029th December, 2015|Blog, Thought Leadership|

TVS adds web interface to its asureSIGN verification tool for real-time requirements management sign-off status

PRESS RELEASE Bristol, UK, 14 January, 2015 – TVS, a leader in software test and hardware verification solutions, today announced the addition of asureVIEWTM to the latest release of its asureSIGNTM management and verification tool. asureVIEW is a web based interface that allows asureSIGN to view real-time status of product requirement and test/coverage results. Bringing confidence [...]

2015-02-24T10:14:00+00:0014th January, 2015|Press Releases, Thought Leadership|

Test and Verification Solutions establishes software test strategy for medical device certification

PRESS RELEASE Bristol, UK, 15th July, 2014 – TVS, a leader in software test and hardware verification solutions, today announced that it has established a unit software testing strategy for Creo Medical, a manufacturer of clinically innovative medical devices, thereby highlighting the breadth of its operations and underpinning the trust placed in it by customers [...]

2015-02-24T10:22:27+00:0015th July, 2014|Compliance, Press Releases, Thought Leadership|