Latest news with #BSI
Scotsman
3 hours ago
- Health
- Scotsman
Webinar welcomes national standards body for support on navigating new legislation
A free webinar has encouraged medical device innovators to learn more about new Post-Market Surveillance (PMS) legislation and how to successfully navigate it. Sign up to our Scotsman Money newsletter, covering all you need to know to help manage your money. Sign up Thank you for signing up! Did you know with a Digital Subscription to The Scotsman, you can get unlimited access to the website including our premium content, as well as benefiting from fewer ads, loyalty rewards and much more. Learn More Sorry, there seem to be some issues. Please try again later. Submitting... Hosting the educational session on Wednesday, June 25 – entitled ' The new Post-Market Surveillance legislation for medical devices - what you need to know' – formal NHS Scotland partner InnoScot Health believes it was a key opportunity to better understand the changes for Great Britain. The changes are intended to improve the safety of medical devices – including in vitro diagnostics (IVD) and active implantable devices – while providing certainty for manufacturers. Advertisement Hide Ad Advertisement Hide Ad Part of wider regulatory reform, the amended regulation will, the Medicines and Healthcare products Regulatory Agency (MHRA) says, 'introduce clearer and more risk-proportionate PMS requirements'. Head of Innovation, Robert Rea, InnoScot Health The 'lunch and learn' webinar was presented by Head of Regulatory Affairs Elaine Gemmell, who provided an overview of the complexities of the current landscape and outlined why it is vital to receive professional advice in order to navigate it successfully. She was joined by guest speakers from The British Standards Institution (BSI) – Damon Williams, Sales Manager – Medical Devices, UK & Ireland, and Umar Butt, Business Development Manager, North UK and Ireland. The national standards body of the United Kingdom, BSI is recognised through a Memorandum of Understanding with the UK Government, producing technical standards on a wide range of products and services. Advertisement Hide Ad Advertisement Hide Ad They spoke on the similarities and key deviations the UK PMS regulation has from EU MDR/IVDR and anticipated changes. User (UGC) Submitted Elaine said: 'Our June webinar was an opportunity to gain a more in-depth understanding of what is crucial new legislation for medical device manufacturers. 'Never more have we needed transformative approaches to healthcare for better patient outcomes, and new medical device breakthroughs are a key driver in realising that goal. 'But clearer, more robust post-market surveillance requirements are necessary to improve safety for both patients and public alike, and in greater alignment with international standards. Advertisement Hide Ad Advertisement Hide Ad 'In response, we now have an important amendment this month and manufacturers are advised to learn more. 'We believe attendees found it useful and instructive in taking practical steps.' The webinar was rounded off by an opportunity to ask questions of the speakers. The medical device industry has experienced unprecedented growth over recent years, and changes to the regulatory landscape mean it is vital innovators get the right advice, support and signposting to develop effective and innovative healthcare products.
Yahoo
3 days ago
- Business
- Yahoo
Avvio Medical Proudly Announces ISO 13485 Certification, Marking a Major Milestone in Global MedTech Readiness
SAN FRANCISCO, June 26, 2025--(BUSINESS WIRE)--Avvio Medical, Inc., a clinical-stage medical device company focused on transforming the treatment of kidney stone disease, is proud to announce that it has successfully achieved ISO 13485:2016 certification following its initial audit conducted by BSI (British Standards Institution). This globally recognized certification demonstrates Avvio's compliance with international standards for medical device quality management systems and reflects the company's unwavering commitment to excellence, patient safety, and operational rigor. "This milestone is more than a regulatory requirement—it represents the fulfillment of our promise to stand up a full-scale medical device company," said Paul Molloy, CEO of Avvio Medical. "Through disciplined execution, a culture of continuous improvement, and a mindset grounded in honor, behavioral integrity, and precision, we have built a foundation for scalable, global operations." He added, "The quality culture at Avvio is not just a box-checking exercise. We embed it through storytelling, structured messaging, and principles drawn from disciplines of Lean and KAIZEN and a culture Bushidō. As we shared with the BSI audit team, our internal motto is #ImproveEverything—and this certification illustrates that we live by it." The ISO 13485 certification now enables Avvio to fully qualify its manufacturing and design processes for commercial scaling, pursue CE marking for international distribution, and reinforce confidence among global partners, investors, and regulators. The achievement is a major step toward the company's upcoming 2026 commercial launch in the U.S. market. With this certification, Avvio affirms that it is not only compliant—but built to lead. About the Enhanced Lithotripsy System (ELS) The AVVIO ELS introduces microbubble enhanced acoustic cavitation lithotripsy that enables kidney stone treatments to move out of the traditional operating room and into more accessible outpatient and office-based settings. The system provides a single, minimally invasive therapy suitable for Ambulatory Surgery Centers (ASCs) and cystoscopy suites, without requiring general anesthesia, fluoroscopy, or costly capital equipment. This innovation offers compelling clinical and economic advantages for both patients and providers. About Avvio Medical Avvio Medical is a privately held medical technology company based in San Francisco and dedicated to transforming the treatment of urinary stones. Its breakthrough platform is designed to improve patient experience, reduce healthcare costs, and expand access to care by offering a fast, minimally invasive solution suitable for a wide range of clinical settings. The company's system eliminates the routine need for general anesthesia or X-ray imaging, streamlining the treatment pathway for both patients and healthcare professionals. View source version on Contacts Media Contact: Paul MolloyChief Executive OfficerAvvio Medical, Tel: (415) 887-2037
Business Wire
3 days ago
- Business
- Business Wire
Avvio Medical Proudly Announces ISO 13485 Certification, Marking a Major Milestone in Global MedTech Readiness
SAN FRANCISCO--(BUSINESS WIRE)-- Avvio Medical, Inc., a clinical-stage medical device company focused on transforming the treatment of kidney stone disease, is proud to announce that it has successfully achieved ISO 13485:2016 certification following its initial audit conducted by BSI (British Standards Institution). This globally recognized certification demonstrates Avvio's compliance with international standards for medical device quality management systems and reflects the company's unwavering commitment to excellence, patient safety, and operational rigor. 'This milestone is more than a regulatory requirement—it represents the fulfillment of our promise to stand up a full-scale medical device company,' said Paul Molloy, CEO of Avvio Medical. 'Through disciplined execution, a culture of continuous improvement, and a mindset grounded in honor, behavioral integrity, and precision, we have built a foundation for scalable, global operations.' He added, 'The quality culture at Avvio is not just a box-checking exercise. We embed it through storytelling, structured messaging, and principles drawn from disciplines of Lean and KAIZEN and a culture Bushidō. As we shared with the BSI audit team, our internal motto is #ImproveEverything—and this certification illustrates that we live by it.' The ISO 13485 certification now enables Avvio to fully qualify its manufacturing and design processes for commercial scaling, pursue CE marking for international distribution, and reinforce confidence among global partners, investors, and regulators. The achievement is a major step toward the company's upcoming 2026 commercial launch in the U.S. market. With this certification, Avvio affirms that it is not only compliant—but built to lead. About the Enhanced Lithotripsy System (ELS) The AVVIO ELS introduces microbubble enhanced acoustic cavitation lithotripsy that enables kidney stone treatments to move out of the traditional operating room and into more accessible outpatient and office-based settings. The system provides a single, minimally invasive therapy suitable for Ambulatory Surgery Centers (ASCs) and cystoscopy suites, without requiring general anesthesia, fluoroscopy, or costly capital equipment. This innovation offers compelling clinical and economic advantages for both patients and providers. About Avvio Medical Avvio Medical is a privately held medical technology company based in San Francisco and dedicated to transforming the treatment of urinary stones. Its breakthrough platform is designed to improve patient experience, reduce healthcare costs, and expand access to care by offering a fast, minimally invasive solution suitable for a wide range of clinical settings. The company's system eliminates the routine need for general anesthesia or X-ray imaging, streamlining the treatment pathway for both patients and healthcare professionals.
India.com
3 days ago
- Business
- India.com
LIC Ranks 4th In Top 10 List Of Most Valuable Indian Brands For 2025
Mumbai: The government-owned insurance giant Life Insurance Corporation of India (LIC) ranked 4th among the 10 most valuable brands in India, according to the Brand Finance India 100 report for 2025. The report notes that LIC's 2025 brand value stood at $13.6 billion, up 35.1 per cent from its 2024 brand value of $10.07 billion. LIC reigns supreme among the top brands ranked in the Indian insurance sector. The public sector giant claimed the position of the world's third strongest insurance brand, ranked by Brand Finance's 2025 Global Insurance 100 report, achieving a BSI score of 87.9/100. Based on Brand Finance's market research data, LIC is perceived as a brand with high familiarity and appeal in its home market, alongside its sustained AAA brand strength rating. Back in the list of top 10 firms by market capitalisation, LIC stands at the 8th spot with a market capitalisation of Rs 5.98 lakh crore, backed by a 38 per cent year-on-year growth in its Q4FY25 consolidated net profit at Rs 19,039 crore compared with Rs 13,782 crore in the year-ago period. The state insurer announced a final dividend of Rs 12 per equity share for the financial year ended March 31. The India 100 2025 by brand value list is based on an assessment of over 200 Indian brands, spanning many sectors, including IT services, hospitality, automotive, pharma, tyres, and retail. The methodology takes into account the latest available audited financials of companies. LIC reported a 13.79 per cent year-on-year increase in group premium for May this year. For the first two months of the financial year 2025-2026, group premium grew 13.66 per cent, according to data compiled by the Life Insurance Council. In May 2025, LIC collected Rs 14,374.87 crore in group premiums, up from Rs 12,632.26 crore in May 2024. The overall new business premium grew 10.27 per cent from Rs 16,690.39 crore in May 2024 to Rs 18,405.04 crore in May this year. The overall life insurance industry garnered Rs 30,463.20 crore, marking a 12.68 per cent rise over Rs 27,034.14 crore collected in the same month last year.
Korea Herald
4 days ago
- Business
- Korea Herald
Business sentiment for July pessimistic over prolonged manufacturing slump: poll
South Korea's business sentiment remains pessimistic for July, a poll showed Wednesday, as a protracted downturn in manufacturing continues to weigh on corporate confidence. The business survey index of the country's top 600 companies by sales stood at 94.6 for next month, according to the monthly poll by the Federation of Korean Industries. A reading below 100 means pessimists outnumber optimists, while a figure above the benchmark means the opposite. The index has now remained below 100 for 40 consecutive months since April 2022. The BSI for manufacturing sectors stood at 86.1, compared with 103.4 for nonmanufacturing sectors. Manufacturing sentiment has stayed negative for 16 months, while the service sector index rebounded for the first time in seven months. Within manufacturing, only the food, beverage and tobacco sectors combined showed a positive outlook. Among nonmanufacturing sectors, lodging, dining, logistics and retail led the gains. "Service sector business confidence is showing signs of recovery due to expectations for fiscal stimulus and summer travel demand," an FKI official said. "But bolstering export competitiveness and the preemptive response to trade friction remain critical for the recovery of manufacturing industries." (Yonhap)
