Tag Archives: Compliance

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 such as IEC 62304, ISO 14971 and IEC 60601. Read More


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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.

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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 to and making it easier for users, asureVIEW gives a pictorial view of accurate information about the verification efforts for both hardware and software projects. The information collected and the analysis tool provided is particularly useful for verification or test engineers and for program managers.

asureSIGN is a requirements driven management and verification tool for managers, developers and integrators. Based on a Requirements Driven Verification and Test (RDVT) flow, it helps to ensure that product requirements have been successfully tested and implemented thus supporting compliance to various safety standards.

The latest asureSIGN release also includes the ability to merge information from multiple sources. This means that information from simulation can be merged with formal verification results from OneSpin Solutions, further differentiating asureSIGN as the industry’s only tool that can combine results from formal and simulation from multiple vendors.

 

TVS-PR019_asureVIEW_Screeshot

 

Demonstrably, TVS is constantly upgrading and developing new products to ensure that its test and verification tools continue to give its customers the tools they need to address projects efficiently, saving on time and costs, and importantly enabling them to become leaders in their own fields too. Furthermore, TVS is currently working closely with companies involved in the automotive, rail and avionics industries towards another major asureSIGN release in March 2015.

A full and detailed list of asureSIGN features can be found on the TVS website at: www.testandverification.com/solutions/requirements/.

About TVS
TVS (Test and Verification Solutions Ltd) provides services and products to organisations developing complex products in the microelectronics and embedded systems industries. Such organisations use TVS to verify their hardware and software products, employ industry best practice and manage peaks in development and testing programmes. TVS’ embedded software testing services includes onsite/offshore testing support including assistance with safety certification and security testing. TVS hardware verification services include onsite/offshore verification support and training in advanced verification methodologies. TVS also offers Verification IPs and its own Verification (EDA) signoff tool.

TVS Company Contact
Dr. Mike Bartley – TVS
+44 7796 307958
[email protected]

Media Contact
Oliver Davies – Publitek Technology PR
+44 1225 470000
[email protected]

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 working in critical fields.

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