Latest news with #ISO-13485
The Hindu
05-07-2025
- Health
- The Hindu
KCS notified as authorised body to inspect medical devices manufacturing facilities
The Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare, has notified the Kalam Institute of Health Technology (KIHT) Certification Services (KCS) as the State's first regulatory body authorised to inspect the manufacturing facilities for Class A and Class B medical devices, according to a release here. Among the 14 such notified bodies nationwide, KCS is the only one operational in Andhra Pradesh and Telangana, marking a milestone in the region's quality management capabilities. Founded in July 2017, the KIHT, located on the AMTZ campus, is a Central government project supported by the Department of Biotechnology. It promotes and supports innovations in medical technologies through research and development, industry promotion, policy-making and knowledge repository. Founded in April 2022, the KCS is accredited by the National Accreditation Board for Certification Bodies (NABCB). The organisation offers comprehensive services, including ISO- 13485 certification, quality systems audit, risk management training, and CE‐mark consultancy — making it a full service hub for manufacturers seeking to meet global regulatory standards. This approval brings immediate benefits to domestic manufacturers, particularly the MSMEs, by eliminating the need for audits outside the State — resulting in significant time and cost savings. It also reinforces Andhra Pradesh's MedTech credentials, supporting national campaigns like 'Make in India' and 'ACI manufacturing', while making the region highly attractive for future investments. This significant milestone empowers KCS to conduct independent regulatory audits for medical device manufacturers in accordance with the Medical Devices Rules (MDR)-2017 for Class A (low risk) and Class B (moderate risk), the release added, while underscoring the State's reputation as a business-friendly hub, ready to meet rising global demand in healthcare.
Associated Press
17-03-2025
- Business
- Associated Press
RetinaLogik Secures $1.1M in Funding and Health Canada Class II Approval, Advancing the Future of Eye Care
CALGARY, Alberta--(BUSINESS WIRE)--Mar 17, 2025-- RetinaLogik Inc., a Calgary-based startup, is proud to announce it has successfully completed a $1.1 million funding round and has received Health Canada's Class II medical device approval for its cutting-edge technology. These milestones will accelerate the adoption of RetinaLogik's VR-AI-powered platform, enabling eye care professionals to perform essential tests—including visual field exams—more efficiently while enhancing the patient experience with a portable headset. The device, which is ISO-13485 and MDSAP Certified as well as FDA registered, is designed with patient comfort in mind, offering a streamlined testing process that significantly reduces both the time required for exams and the cost of equipment. In fact, the RetinaLogik system can reduce upfront costs by up to 90% compared to traditional equipment. It also features multilingual support, helping to bridge communication gaps in the clinic. Dr. Sarhan, CEO of RetinaLogik, expressed his enthusiasm about the progress: 'Achieving these milestones marks a proud moment for our organization. We've developed a solution that not only makes eye care more efficient but also more affordable and accessible. With the support of our investors and partners, we're excited to continue growing and improving the future of eye care for everyone. This is just the start, stay tuned for more!' Nikhi Operating Partner, UCeed Funds, shared: 'We have proudly supported the RetinaLogik team since their earliest stages and are thrilled to deepen our commitment by doubling down on our investment in the company. Over the past two years, the RetinaLogik team has built a groundbreaking VR platform that delivers unparalleled clinical reliability for functional eye exams.' This was also emphasized by Graham Day, Managing Partner, Spring Impact Capital: 'Spring Impact Capital is proud to have co-led this round for RetinaLogik, which is proving strong market demand for its product. By enhancing access to quality eye care diagnostics and improving clinic efficiency, they are set to make a meaningful impact on communities while achieving commercial success. We're excited to support Abdullah, Julia, and the team in this next phase.' This milestone wouldn't be possible without the support from the community such as Alberta Innovates. Trevor Lynn, Vice Precident of Health in Alberta Innovates adds: 'Alberta Innovates congratulates RetinaLogik on obtaining it's Health Canada Class II licence through support from the Accelerating Innovations into CarE (AICE) program. This accomplishment is an example of Alberta's success commercializing health innovation to improve the patient experience and enable easier patient care access in the community.' With these milestones, RetinaLogik reaffirms its commitment to advancing high-quality vision screening and monitoring to provide more insights for specialists. The company plans to expand adoption of its platform across North America and beyond, helping to close critical gaps in eye care. By enabling earlier detection and treatment of vision-threatening conditions, RetinaLogik aims to prevent irreversible vision loss and improve patient outcomes. (587) 741-4565 SOURCE: RetinaLogik Inc. Copyright Business Wire 2025. PUB: 03/17/2025 05:00 AM/DISC: 03/17/2025 04:59 AM
