BSI Group

Unaric acquires Asperato, a UK Salesforce Software Vendor and Payment Solutions Provider

Retrieved on: 
화요일, 4월 9, 2024
Salesforce, Real estate, Harley-Davidson, Automotive industry, Entrepreneurship, BSI, ISV, Acquisition, BSI Group, Management

The application integrates with 26 payment providers and processes over $1.2 B USD annually on behalf of their customers.

Key Points: 
  • The application integrates with 26 payment providers and processes over $1.2 B USD annually on behalf of their customers.
  • The business has a significant presence in the UK, APAC and the USA with customers in the Real Estate, High-Tech, Automotive industries.
  • Our already experienced team is eager to embrace this next phase, enriched by the added resources and expertise from Unaric.
  • This acquisition intensifies our pursuit of success in the Salesforce ecosystem as we continue to deliver unparalleled payment experiences and solutions on behalf of our customers."

Xlife Sciences AG Announces Collaboration Agreement Between its Portfolio Company FUSE-AI GmbH and T-Systems Switzerland

Retrieved on: 
수요일, 4월 10, 2024
Cloud, European Economic Area, MRI, CE, Partnership, Research, Science, Radiology, AI, Software, T-Systems, EEA, MDR, PACS, BSI Group, Health, BSI, Medical device

Xlife Sciences is pleased to announce a collaboration between its portfolio company, FUSE-AI, and T-Systems Switzerland.

Key Points: 
  • Xlife Sciences is pleased to announce a collaboration between its portfolio company, FUSE-AI, and T-Systems Switzerland.
  • T-Systems Switzerland, as a subsidiary of T-Systems International GmbH, is considered a system-relevant IT and digitalization partner in the healthcare sector in Switzerland.
  • Through this cooperation, T-Systems Switzerland distributes the AI-based solution for prostate analysis from FUSE-AI centrally in Switzerland, thereby enabling the commercialization of «Prostate.Carcinoma.ai» for radiological clinics and practices.
  • Xlife Sciences sees this partnership as a significant contribution to continuing its mission to bridge the gap between innovations and the needs of the healthcare market.

Element Science Receives CE Mark & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator

Retrieved on: 
목요일, 1월 25, 2024
Health, Medical Devices, Technology, Health Technology, Other Health, Wearables, Mobile Technology, Cardiology, BSI, Death, Patient, MDR, SCA, BSI Group, American Heart, Jewel, Multimedia, Survival, Miniaturization, UKCA, Science, European, Algorithm, Sale, Arrest, Arrhythmia, CE marking, Boston Scientific, Machine learning, CE, Medical device

View the full release here: https://www.businesswire.com/news/home/20240125437671/en/

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20240125437671/en/
    Element Science Receives CE Mark & UKCA Mark for the Jewel® Patch-Wearable Cardioverter Defibrillator First of its kind life-saving technology receives CE Mark and UKCA Mark, paving the way for enhanced protection of patients with elevated risk of sudden cardiac arrest.
  • (Photo: Business Wire)
    The Jewel P-WCD was designed to address limitations with traditional garment-based WCDs.
  • The company is now well positioned to plan for delivering this lifesaving technology to patients outside the US."
  • The Jewel P-WCD is limited to investigational use only and is not available for sale in the United States.

iRhythm Technologies Receives European Union’s CE Marking Under Medical Device Regulation (EU MDR) for its Zio® monitor and ZEUS System

Retrieved on: 
수요일, 1월 3, 2024
BSI, MDR, ECG, Hand, Prevalence, Trial of the century, SAN, CE, Certification, Stroke, Arrhythmia, IRTC, ZEUS, Zio, BSI Group, Notified body, European, Patient, Safety, Medical device

The Zio monitor ECG System secured its CE mark based on compliance to EU MDR standards of performance, quality, safety, and efficacy, along with the body of clinical evidence supporting Zio in detecting potential cardiac arrhythmias.

Key Points: 
  • The Zio monitor ECG System secured its CE mark based on compliance to EU MDR standards of performance, quality, safety, and efficacy, along with the body of clinical evidence supporting Zio in detecting potential cardiac arrhythmias.
  • The new Zio monitor is thinner, lighter, and smaller compared to Zio XT to provide a more inconspicuous wear experience.2-4.
  • Early clinical and patient experience in the United States has shown that Zio monitor has even better wear times and analyzable ECG2.
  • Furthermore, the certification incorporates CE mark for the ZEUS (Zio ECG Utilization Software) System, iRhythm’s advanced deep-learned AI algorithm which supports the capture and analysis of ECG data recorded by Zio monitor.

Cobo Achieves ISO 27001 Certification, Showcasing Strengthened Information Security in Institutional Custody

Retrieved on: 
월요일, 12월 18, 2023
Entrepreneurship, BSI, ISMS, Certification, Information management, BSI Group, ISO, Information, Risk management

SINGAPORE, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Cobo, a global leader in digital asset custody solutions, announced it has achieved ISO 27001 certification, the internationally recognized standard for Information Security Management Systems (ISMS). The official certification from BSI Group was received following a rigorous and comprehensive audit process.

Key Points: 
  • SINGAPORE, Dec. 18, 2023 (GLOBE NEWSWIRE) -- Cobo, a global leader in digital asset custody solutions, announced it has achieved ISO 27001 certification, the internationally recognized standard for Information Security Management Systems (ISMS).
  • ISO 27001 is the global benchmark for effective information management, outlining the best practices for organisations to safeguard against potential security breaches.
  • The ISO 27001 certification applies across Cobo’s business systems, including all important information assets and data.
  • “Achieving the ISO 27001 certification demonstrates Cobo’s relentless pursuit of the highest security standards for our systems and customer data,” said Changhao Jiang, Co-Founder and CTO of Cobo.

TRIMEDX receives International Organization for Standardization’s world-class information management security recertification

Retrieved on: 
화요일, 11월 28, 2023
Information, BSI, ISO/IEC 27001:2013, ISMS, Patient safety, MD, International Organization (journal), Certification, Root cause analysis, ISO, BSI Group, Informatics, Safety, SOC 2, SOC, Medical device

Indianapolis, Indiana, Nov. 28, 2023 (GLOBE NEWSWIRE) -- TRIMEDX ―an industry-leading, independent clinical asset management company delivering clinical engineering services, clinical asset informatics, and medical device cybersecurity―has been recertified with the highly regarded International Organization for Standardization’s Information Management Security certification ISO/IEC 27001:2013, a widely recognized international standard outlining best practices for information security management.

Key Points: 
  • Indianapolis, Indiana, Nov. 28, 2023 (GLOBE NEWSWIRE) -- TRIMEDX ―an industry-leading, independent clinical asset management company delivering clinical engineering services, clinical asset informatics, and medical device cybersecurity―has been recertified with the highly regarded International Organization for Standardization’s Information Management Security certification ISO/IEC 27001:2013, a widely recognized international standard outlining best practices for information security management.
  • This recertification, valid through Dec. 2026, reverifies that TRIMEDX meets the latest information security industry standards while maintaining and enforcing policies and procedures to ensure the security of data.
  • Meeting the standard demonstrates TRIMEDX’s achievement of world-class safety and security management of information.
  • The ISO 27001 certification couples with TRIMEDX’s Service Organization Control (SOC) 2 Type 2 and ISO 13485:2016 certification (valid through Aug. 2024) to make up TRIMEDX’s Quality Management System covering MD QMS and Information Security Management System (ISMS) standards.

Customs Audit Market to grow by USD 3.61 billion from 2023 to 2028; market is fragmented due to the presence of prominent companies like DB Schenker, Baker Tilly International Ltd. and Deloitte Touche Tohmatsu Ltd., and many more - Technavio

Retrieved on: 
수요일, 11월 15, 2023
LLP, Tax, Ryan LLC, XPO, Inc., Intertek, PwC, USD, DB Schenker, United Parcel Service, BDO Global, Growth, Geography, BSI Group, KPMG, Legislation, Accounting, Music

NEW YORK, Nov. 15, 2023 /PRNewswire/ -- The customs audit market is estimated to grow by USD 3.61 billion from 2023 to 2028, growing at a CAGR of 6.44%.

Key Points: 
  • NEW YORK, Nov. 15, 2023 /PRNewswire/ -- The customs audit market is estimated to grow by USD 3.61 billion from 2023 to 2028, growing at a CAGR of 6.44%.
  • The customs audit market is fragmented owing to the presence of many global and regional companies.
  • Deloitte Touche Tohmatsu Ltd. - The company offers customs audits to deliver a systematic framework to multinational companies seeking greater transparency into trade data and compliance levels.
  • The foreign exchange market size is estimated to grow at a CAGR of 10.31% between 2023 and 2028.

SS Innovations Appoints Dr. Sonia Shokeen as Head of Quality and Regulatory Affairs

Retrieved on: 
월요일, 10월 30, 2023
Class II, AAMI, Product lifecycle, Johns Hopkins University, SS, Johnson & Johnson, Digital Solutions, Robotics, University, OTC, Johns, Organization, American Society for Microbiology, Society, Mantra, BSI, BSI Group, Partnership, Head, Stroke, Sterilization, Quality function deployment, Quality, SSI, Medtronic, Ethylene oxide, Pharmaceutical industry, Medical device, MD

FORT LAUDERDALE, FL, Oct. 30, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announces the appointment of Dr. Sonia Shokeen as Head of Quality and Regulatory Affairs.

Key Points: 
  • Dr. Shokeen will lead SS Innovations’ Product Lifecycle Management, Quality System Management, regulatory strategy, and international submissions.
  • Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, said, “Dr.
  • Shokeen brings a wealth of experience to this role, and I am delighted to welcome her to the SS Innovations team.
  • Prior to joining SS Innovations, Dr. Shokeen led Quality Function in senior management roles at Johnson and Johnson (Auris Health) in its Robotics and Digital Solutions franchise in Redwood City, CA.

 MetricStream to Preview Enhanced User Experience and Showcase AI Powered GRC, AiSPIRE, at London Summit Next Week

Retrieved on: 
수요일, 10월 11, 2023
Data Management, Security, Technology, Software, Artificial Intelligence, Internet, Nordea, Connection, Risk management, AI, Power lines connecting Vancouver Island with Canadian Mainland, Organization, Risk, BSI Group, Operational risk, GRC, Internal audit, CRA, Artificial intelligence, Siemens Energy, Enterprise, DORA, News, IRM, Face, Connected, Medical device, Management

MetricStream’s GRC Summit, London is an opportunity to strengthen industry connections, drive innovation, and elevate the practice of governance, risk management, and compliance.

Key Points: 
  • MetricStream’s GRC Summit, London is an opportunity to strengthen industry connections, drive innovation, and elevate the practice of governance, risk management, and compliance.
  • In all reality it’s become the year of AI answering the question of how can we possibly do more with less?
  • The GRC Summit will largely focus on answering this question for global risk leaders,” said Prasad Sabbineni, co-CEO, MetricStream .
  • MetricStream leadership along with the panel of speakers will also discuss and share insights from real world case studies.

Neoss® Group receives EU Medical Device Regulation (MDR) certifications for implants and abutments

Retrieved on: 
목요일, 10월 12, 2023
European, Certification, BSI Group, Legislation, MDR, Database, Regulation, Quality management system, Notified body, Netherlands, BSI, MDD, European Medical Devices Industry Group, Patient, Medical device, EU

ZÜRICH, Oct. 12, 2023 /PRNewswire/ -- Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments.

Key Points: 
  • ZÜRICH, Oct. 12, 2023 /PRNewswire/ -- Neoss Group, a leading innovator in dental implant solutions, is proud to announce that it has received EU Medical Device Regulation (MDR) certification by its Notified Body, the BSI Group, the Netherlands B.V. for its implants and abutments.
  • This signifies that Neoss Group's Quality Management System and its implants and abutments meet the requirements of the new MDR implemented by the European Union.
  • The new EU Medical Devices Regulation 2017/745 (MDR) replaces the former European Medical Device Directive 93/42/EEC (MDD), and brings EU legislation into line with technical advances, changes in medical science and progress in law-making.
  • The new MDR regulation contains a series of important improvements including establishing a comprehensive and accessible EU database on medical devices with a device traceability system based on a unique device identification.