Latest news with #ISO13485:2016
Arab Times
2 days ago
- Health
- Arab Times
This technology could change forensics forever — and Kuwait is leading the charge
KUWAIT CITY, July 21: Brigadier Abdul Rahim Mohammed Al‑Awadhi, Director of the Forensic Medicine Department at the General Department of Criminal Evidence (GDCE), affirmed in an interview with Al‑Anba the department's pivotal contribution to criminal investigations through precise scientific analysis. Brig. Al‑Awadhi underscored the department's decisive involvement in major criminal cases solved within record time, including the Imam Al‑Sadiq Mosque bombing, the Hawally 'monster' case involving approximately 18 child rape offenses, and the Jahra wedding tent fire that tragically claimed around 57 lives. He detailed the department's methodical approach: examining the crime scene, transporting the body to the morgue for a thorough autopsy, followed by a comprehensive medical report that scientifically clarifies the cause of death. These findings are coordinated with investigative authorities to inform legal proceedings. Highlighting future enhancements, Brig. Al‑Awadhi announced ongoing efforts to align Kuwait's forensic sciences with international standards. A key initiative includes plans to introduce a virtual autopsy—or "virtopsy"—utilizing advanced imaging like CT and MRI scans to examine bodies without surgical dissection, a non‑invasive alternative being adopted in other countries. He revealed that the department is on the verge of earning multiple international quality certifications—ISO 9001:2015 for quality management and ISO 13485:2016 for medical device standards—underscoring its commitment to meeting rigorous global benchmarks in forensic service delivery and equipment handling. The Forensic Medicine Department comprises several specialized divisions: Living Examination Department: Assesses and documents injuries in cases of assault.n Mortality Examination Department: Determines causes of death, analyzes toxins and injuries.n Pathology or Tissue Examination Department: Investigates tissue-level alterations to ascertain cause of death.n Specialized Clinics Department: Includes radiology, ophthalmology, and dentistry specialists.n Follow-up and Coordination Department: Manages administrative workflows and inter-departmental communication.n Brig. Al‑Awadhi outlined that forensic reports guide criminal investigations by accurately determining critical elements such as time and cause of death, injury patterns, links to crime scenes, and suspect identification—all based on scientific data. He further explained that the GDCE's forensic system can be mobilized for complex cases involving fires or advanced decomposition. In such instances, a multidiscipline task force applies strict protocols and coordinated analysis to deliver prompt and reliable results. Recognizing challenges such as caseload pressure, the need for precision, and confidentiality, the department has established a Quality Control Department and a Coordination Unit. It has also introduced a secure G2G messaging system to transmit forensic reports electronically and discreetly, reducing reliance on paper-based procedures. In support of digital transformation, the department is integrating services with the Ministry of Interior's 'Sahel' application. Upcoming features will allow citizens and residents to receive notifications relating to civil and medical legal processes—including appointment scheduling and case status—enhancing transparency and procedural efficiency. The department is evaluating adoption of virtopsy technology—a forensic imaging system that uses CT and MRI to simulate autopsy findings without dissection. This method has gained traction internationally due to its ability to preserve the integrity of the body and facilitate faster, non-invasive investigations—especially relevant in settings with cultural sensitivities regarding autopsies Brig. Al‑Awadhi also praised the leadership of Sheikh Fahad Al‑Yousef, First Deputy Prime Minister and Minister of Interior, for championing modernization of the forensic sector. He emphasized that Sheikh Al‑Yousef's support is central to the department's development — providing the latest crime detection technologies, promoting continuous professional training, and fostering integration with other Ministry sectors to ensure rapid, transparent justice. Through these efforts, Kuwait's Forensic Medicine Department is advancing toward international leadership in forensic science — enhancing its role as a crucial pillar in both the security and judicial systems.
Bangkok Post
03-07-2025
- Health
- Bangkok Post
Mahidol Lab First in ASEAN with ISO 13485
Mahidol University's Faculty of Engineering has become the first in Thailand and ASEAN to receive ISO 13485:2016 certification for its innovation in antibacterial nano-coatings on dental implants—a milestone that brings the research closer to clinical application and commercialisation. The certification was awarded to the Laboratory of Drug Delivery System for Medical Devices for its nano-coating technology designed to reduce bacterial infections on dental implants. This breakthrough responds to a critical need in dentistry, where up to 80% of implant patients experience mild inflammation and 20% face severe bone loss due to infection. Led by Assoc. Prof. Dr. Noraset Nasongkla and Dr. Chalaisorn Thanapongpibul, in collaboration with the Faculty of Dentistry's Assoc. Prof. Dr. Saranya Tanchareon, the project showcases Mahidol's strength in interdisciplinary research. Assoc. Prof. Dr. Thanapat Wanichanon, Dean of the Faculty of Engineering, credited the achievement to strong collaboration and Mahidol's dedication to research that meets global standards. Assoc. Prof. Dr. Bundit Jirajariyavej, Dean of the Faculty of Dentistry, confirmed that the nano-coated implants will soon undergo clinical trials—an essential step toward real-world use that could improve patient outcomes and reduce reliance on imported technologies. ISO 13485:2016 is a globally recognised standard for quality management systems in medical devices, ensuring that certified organisations consistently meet regulatory and safety benchmarks. 'This certification is more than a symbol—it's a foundation of trust,' said Robert Frolich, Vice President of Medical Health Services (ASEAN) at TÜV SÜD PSB Singapore. This achievement not only elevates Thailand's profile in high-value medical innovation but also underscores Mahidol University's role as a 'University of Innovation,' transforming academic research into impactful, scalable healthcare solutions.
Yahoo
26-06-2025
- Business
- Yahoo
ForSight Robotics raises $125M for cataract surgery platform
This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. ForSight Robotics has raised $125 million as it prepares for first-in-human robotic cataract surgery clinical trials this year. The Israel-based company said this week the funds will support the next phase of growth in the development of its Oryom platform, the world's first robotic surgery platform for cataracts and other eye diseases. Participants in the Series B funding round include Eclipse, Intuitive Surgical co-founder Fred Moll, Adani Group and Reiya Ventures, among other investors. ForSight is scaling up, having identified a need to expand patient access to eye surgery amid a declining number of ophthalmologists and growing demand for vision treatment. The company cited a forecast from researchers at Vanderbilt University pointing to a 12% decline in ophthalmologists by 2035, alongside a projected 24% increase in demand. Joseph Nathan, ForSight co-founder and chief medical officer, said in a statement that the urgent global need presents an 'immense' opportunity for the company. 'We see ophthalmology as the next frontier in the robotics revolution – much like general surgery was before the rise of Intuitive Surgical,' said Nathan. Starting with cataract surgery, ForSight's platform aims to offer surgeons the dexterity, maneuverability and ergonomics to provide precise and consistent ophthalmic procedures, according to the company. The platform is designed to allow surgeons to navigate complex angles to reach any point in the eye, enabling glaucoma and retinal surgical treatment. 'The company is tapping into a massive, underserved market,' said Eclipse partner Seth Winterroth. ForSight said more than two dozen ophthalmic surgeons have successfully completed hundreds of procedures on animal eye models using its platform. In February, it received ISO 13485:2016 certification, an international benchmark for quality management systems in the medical device industry. The company completed a $55 million funding round in 2022, and has raised a total of $195 million to date. Recommended Reading 4 robotic surgery trends to watch in 2025 Sign in to access your portfolio
Business Wire
26-06-2025
- 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.
Yahoo
16-06-2025
- Business
- Yahoo
TekniPlex opens facility in Wisconsin
TekniPlex Healthcare has initiated production at its newly established 200,000ft² facility in Madison, Wisconsin. Located at 6002 Femrite Drive, this site is expected to enhance the company's Barrier Protection Systems business. According to the company, the new location seeks to merge manufacturing technologies with expertise in materials science. This strategy aims to broaden capabilities and improve access to protective solutions throughout North America and internationally. This facility will help boost TekniPlex Healthcare's support for medical device and pharmaceutical firms. It is designed to ensure 'reliable' access to sterile barrier packaging for hospitals, outpatient surgical centres, laboratories, and patients, stated the company. The Madison plant has received ISO 13485:2016 quality management system certification. As TekniPlex Healthcare's second site in Madison, it will concentrate on creating coated and printed solutions. These products are crucial for safeguarding medical devices and wound care products from contaminants, ultimately enhancing patient outcomes. The new plant is equipped with modern manufacturing infrastructure, including an air knife coater, added the company. This machinery will help the company boost the supply of coated Tyvek and heat-seal coated reinforced papers for various sterilisation barrier applications. Furthermore, the facility features a wide-width eight-colour high-definition flexographic printing press. This technology enables TekniPlex Healthcare to fulfil stringent healthcare printing requirements while maintaining a near-zero waste manufacturing process. Sustainability is a primary focus for the new facility, which has adopted an eco-friendly design approach. The company states that at least 95% of the waste produced by the facility is recyclable. Looking forward, the facility has plans for future expansion opportunities. These include the addition of a second flexographic printer, a cantilevered slitter rewinder, and a reversible salvage rewinder. TekniPlex Healthcare CEO Suj Mehta said: 'Our new flagship facility exemplifies TekniPlex Healthcare's mission of improving patient care through solutions that protect, preserve, and perform. The products manufactured here directly impact patients' lives. 'As a dedicated hub, the site not only expands our capacity and provides customers with supply chain assurances, but also serves as a knowledge base to build upon and maximise our leadership in barrier protection materials science.' In October 2024, TekniPlex Healthcare introduced its new bio-based medical-grade polyvinyl chloride compounds. "TekniPlex opens facility in Wisconsin" was originally created and published by Packaging Gateway, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Sign in to access your portfolio
