Conformance testing

NAMSA First to Receive FDA ASCA Accreditation for Medical Device Biocompatibility Testing

Retrieved on: 
Wednesday, July 28, 2021
Science, Biotechnology, Research, General Health, Health, Consulting, Medical devices, Professional services, Standards, Product testing, Medical device, Medical devices, Product, Conformance testing, Food and Drug Administration, Government, Evaluation

The ASCA Pilot Program , a first-of-its-kind conformity assessment program created by the U.S. FDA, reduces the regulatory burden on medical device manufacturers through consensus of biocompatibility testing requirements for efficiency.

Key Points: 
  • The ASCA Pilot Program , a first-of-its-kind conformity assessment program created by the U.S. FDA, reduces the regulatory burden on medical device manufacturers through consensus of biocompatibility testing requirements for efficiency.
  • Founded in 1967 , NAMSA was the first independent company in the world to focus solely on testing medical device materials for safety.
  • Today, the organization conducts over 100,000 tests annually to assist medical device innovators meet global testing requirements, mitigate biological risks and ensure medical device safety for end users.
  • Helping medical device Sponsors improve healthcare since 1967, NAMSA is the only 100% medical device-focused, full continuum Contract Research Organization (CRO).

Global Managed Testing Services Market (2021 to 2026) - Growth, Trends, COVID-19 Impact, and Forecasts - ResearchAndMarkets.com

Retrieved on: 
Monday, July 26, 2021
Health, Technology, Other Technology, Other Health, Software, Pharmaceutical, Biotechnology, Software testing, Quality management, Software engineering, Articles, Test automation, Interoperability, NextGen Connect, Conformance testing, Functional testing

Some of them are listed below --

Key Points: 
  • Some of them are listed below --
    Functional Testing -- Testing of healthcare workflows across the enterprise (e.g.
  • MESA, DVTK, Mirth)
    Conformance Testing -- Testing conformance to healthcare industry frameworks and security requirements (e.g.
  • Meaningful Use, HIPAA, FDA requirements, VA requirements)
    Interoperability Testing -- Testing conformance to interoperability standards (e.g.
  • QA Consultants' skilled Test Automation experts developed both an automation framework and scripts for use in their regular regression testing.

LitePoint Provides First Ultra-Wideband PHY Tester Validated for FiRa Consortium PHY Conformance

Product testing, Software testing, FiRa Consortium, Tests, Computing, Technology, Fira, PHY, LitePoint, Conformance testing, Test automation, Device under test

LitePoints IQgig-UWB test platform has achieved the status of Validated Test Tool for the FiRa Consortium by successfully completing all the requirements for PHY conformance verification.

Key Points: 
  • LitePoints IQgig-UWB test platform has achieved the status of Validated Test Tool for the FiRa Consortium by successfully completing all the requirements for PHY conformance verification.
  • This test solution is now available for Authorized Test Labs (ATLs) for PHY Conformance Certification testing or by FiRa members as part of pre-certification testing.
  • We are proud that our IQgig-UWB platform is now the first PHY tester validated by FiRa for its Certification Program.
  • IQfact+ application software provides complete automation for PHY conformance testing including tester control, Device Under Test (DUT) control, and data collection.

DEARhealth becomes one of the world's first companies to obtain CE-marking according to new European Union Medical Device Regulation (MDR)

Retrieved on: 
Wednesday, June 9, 2021
Regulation, Articles, Medical device, Quality management, Regulation (EU) 2017/745, Medical software, Evaluation, Conformance testing, Regulation (EU) 2017/746, Regulation (EU) No. 305/2011, MDR, Quality management system

The CE-mark allows DEARhealth to market its medical software commercially in the European Union.

Key Points: 
  • The CE-mark allows DEARhealth to market its medical software commercially in the European Union.
  • CE-marking according to MDR assures health systems and pharmaceutical companies that a software as a medical device complies to European Union regulation and meets a high standard of quality and safety requirements.
  • "Our partnersin both the US and Europecan be confident that we design and manufacture our medical device software under high standards of quality and safety.
  • Following a successful conformity assessment, including an audit of the quality management system, DEARhealth is among the first 250 manufacturers to obtain CE-marking according to MDR for their medical device software.

 TÜV SÜD North America Gains U.S. FDA (Food & Drug Administration) ASCA Accreditation for Medical Device Testing

Retrieved on: 
Thursday, April 29, 2021
FDA, Medical devices, Supply chain management, Health, Retail, Regulation, Medical technology, Articles, ISO 13485, Medical equipment, Medicine, Medical device, Product testing, Food and Drug Administration, Notified Body, Conformance testing

b"T\xc3\x9cV S\xc3\x9cD, a trusted global partner offering a comprehensive portfolio of testing, certification, auditing, and advisory services, recently announced their acceptance into the Food & Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for medical device safety and performance testing.

Key Points: 
  • b"T\xc3\x9cV S\xc3\x9cD, a trusted global partner offering a comprehensive portfolio of testing, certification, auditing, and advisory services, recently announced their acceptance into the Food & Drug Administration (FDA) Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program for medical device safety and performance testing.
  • Since 1866, the company has remained committed to its founding principle of protecting people, property and the environment from technology-related risks.
  • Visit www.tuvsud.com\nT\xc3\x9cV S\xc3\x9cD America Inc., a subsidiary of T\xc3\x9cV S\xc3\x9cD AG (Munich, Germany), is a leading globally recognized testing and certification organization.
  • T\xc3\x9cV S\xc3\x9cD America also provides a comprehensive suite of services for the medical device sector as a European Union notified body for the medical device, active implantable medical device and in-vitro diagnostic device directives, and a complete service portfolio including ISO 13485 and MDSAP certification, FDA 510(k) and third-party inspections.

Sovereign Pharmaceuticals Becomes First Manufacturer to Earn All GS1 EPCIS Trustmarks for FDA DSCSA Interoperability Mandate

Retrieved on: 
Thursday, February 25, 2021
Product testing, Regulation, EPCIS, Standards organizations, GS1, Articles, Conformance testing, Interoperability

EPCIS is a GS1 Standard that enables trading partners to share accurate and detailed information about the physical movement and status of products.

Key Points: 
  • EPCIS is a GS1 Standard that enables trading partners to share accurate and detailed information about the physical movement and status of products.
  • Drummond is an approved GS1 conformance testing partner and its automated conformance test tools enable organizations to assess their EPCIS messages for compliance with the DSCSA rule.
  • "Utilizing Drummond's highly intuitive EPCIS Interoperability Conformance Checker , a web-based portal tool, was key to gaining the GS1 Trustmarks with speed and efficiency."
  • We are proud of our collaboration with Sovereign as it marks this milestone as the first to earn all manufacturer GS1 EPCIS Trustmarks."

Global Testing, Inspection, and Certification Markets, 2020-2025: Service Innovations and Adjacent Market Penetration Opportunities Enabled by 5G, IoT, AI/ML, and Environmental Sustainability

Retrieved on: 
Wednesday, February 17, 2021
Articles, Business, Regulation, Standards, Quality assurance, Quality, Certification mark, Trademark law, Conformance testing, Accreditation, Certification, Outsourcing

In the global testing, inspection, and certification (TIC) market independent conformity assessments are carried out by regulatory bodies, accredited and certified third-party companies, and organizations.

Key Points: 
  • In the global testing, inspection, and certification (TIC) market independent conformity assessments are carried out by regulatory bodies, accredited and certified third-party companies, and organizations.
  • This study analyzes the dynamics and market potential of outsourced third-party independent TIC companies and excludes in-house testing.
  • The global TIC market is fragmented and intensely competitive, characterized by a few global players and numerous participants at the regional level.
  • The Impact of the Top 3 Strategic Imperatives on the Global Testing, Inspection, and Certification Market

Global Testing, Inspection, and Certification Market Report 2020: Digital Transformation Powers the Industry - Forecast to 2025 - ResearchAndMarkets.com

Retrieved on: 
Monday, February 15, 2021
Technology, Other Technology, Regulation, Standards, Evaluation, Quality assurance, Quality, Product testing, Certification mark, Trademark law, Accreditation, Conformance testing, Inspection, Professional certification

The "Digital Transformation Powers the Global Testing, Inspection, and Certification Market" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Digital Transformation Powers the Global Testing, Inspection, and Certification Market" report has been added to ResearchAndMarkets.com's offering.
  • In the global testing, inspection, and certification (TIC) market independent conformity assessments are carried out by regulatory bodies, accredited and certified third-party companies, and organizations.
  • The global TIC market is fragmented and intensely competitive, characterized by a few global players and numerous participants at the regional level.
  • The Impact of the Top 3 Strategic Imperatives on the Global Testing, Inspection, and Certification Market

Automotive Testing, Inspection, and Certification - Global Market Outlook 2019-2027: Rising Occurrence of Vehicle Recall Owing to Component Failures and Growing Production in Emerging Economies - ResearchAndMarkets.com

Retrieved on: 
Thursday, December 10, 2020
Automotive Manufacturing, Manufacturing, Other Automotive, General Automotive, Automotive, Standards, Quality assurance, Testing, inspection and certification, Certification mark, Conformance testing, Evaluation, Methodology, Articles

The "Automotive Testing, Inspection, and Certification - Global Market Outlook (2019-2027)" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Automotive Testing, Inspection, and Certification - Global Market Outlook (2019-2027)" report has been added to ResearchAndMarkets.com's offering.
  • Global Automotive Testing, Inspection, and Certification market accounted for $16.12 billion in 2019 and is expected to reach $26.29 billion by 2027 growing at a CAGR of 6.3% during the forecast period.
  • While the factors like the rising occurrence of vehicle recall owing to component failures and growing automobile production in emerging economies are propelling the market growth.
  • The automotive testing, inspection and certification sector consists of conformity assessment bodies that supply services ranging from auditing and inspection to testing, quality guarantee, authentication, and certification.

Keysight Launches New 800G Test Solutions to Speed Development of Next Generation Data Center Technologies

Retrieved on: 
Thursday, December 10, 2020
Technology, Mobile, Wireless, Engineering, Manufacturing, Other Technology, Telecommunications, Software, Networks, Internet, Hardware, Other Manufacturing, Electronic design automation, Semiconductor, VoIP, Hewlett-Packard, Keysight, Conformance testing, Companies, Branches of science, Metrology

Keysight Technologies, Inc. (NYSE: KEYS), a leading technology company that helps enterprises, service providers and governments accelerate innovation to connect and secure the world, has launched new 800G test solutions for validating electrical and optical interfaces to speed development of next generation data center technologies, including the first 100Gb/s transmitter and receiver pre-conformance test solution.

Key Points: 
  • Keysight Technologies, Inc. (NYSE: KEYS), a leading technology company that helps enterprises, service providers and governments accelerate innovation to connect and secure the world, has launched new 800G test solutions for validating electrical and optical interfaces to speed development of next generation data center technologies, including the first 100Gb/s transmitter and receiver pre-conformance test solution.
  • Service providers and data center operators are seeking 800G technology to meet a growing demand in network capacity at the desired cost and power consumption targets.
  • Keysights new 800G test solutions allow users to fully explore design margins, while addressing design and conformance validation challenges in an 800G transceiver market , which is expected to reach $2.5 billion by 2029 according CIR.
  • New Keysight 800G test solutions include:
    The first pre-conformance test solution for validating both transmitter and receiver electrical signaling input interfaces according to the 100Gb/s standard currently under development by IEEE and OIF.