Tag Archives: certification

ISO 27001 – information security standard for Modulight

February 28, 2024 by Modulight
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Modulight achieved the international ISO 27001 information security standard certification today on February 28, 2024. The certification of the information security management system demonstrates the organization’s commitment to protecting information and managing high-level of information security. “We are expanding the use of cloud services in accordance with our SaaS business model and are making strong progress in transitioning to a pay-per-treatment (PPT) payment model. Managing patient information requires very high-level information security processes, which is why we started to pursue the ISO 27001 certification in Continue reading →Modulight achieved the international ISO 27001 information security standard certification today on February 28, 2024. The certification of the information security management system demonstrates the organization's commitment to protecting information and managing high-level of information security. "We are expanding the use of cloud services in accordance with our SaaS business model and are making strong progress in transitioning to a pay-per-treatment (PPT) payment model. Managing patient information requires very high-level information security processes, which is why we started to pursue the ISO 27001 certification in Continue reading →

Protected: Workshop on the best practices in clinical photodynamic therapy Password Protected

August 14, 2015 by Modulight
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There is no excerpt because this is a protected post.Fri 24th April 6 pm, Gaylord Palms Resort, Kissimmee, FL Topics PDT dosimetry – Dr. Gal Shafirstein, Roswell Park Cancer Center, Buffalo, NY [embeddoc url="https://modulight.com/wp-content/uploads/2015/08/ASMLS-2015-PDT-Workshop-Prof.-Shafirstein-Final.pptx" width="280px" height="210px" download="all" viewer="microsoft"] Head & Neck – Dr. Merrill Biel, University of Minnesota Medical School, Minneapolis, MN Cholangiocarsinoma & Esophageal – Dr. Herbert C. Wolfsen, Mayo Clinic, Jacksonville, FL [embeddoc url="https://modulight.com/wp-content/uploads/2015/08/ASLMS_2015_Jones-Wolfsen.pptx" width="280px" height="210px" download="all" viewer="microsoft] Thoracic PDT – Dr. Patrick Ross Jr, The Ohio State University, Columbus, OH Mesothelioma – Dr. Keith Cengel, Perelman School of Medicine, Philadelphia, PA Breast – Dr. Continue reading →

Modulight launches the world’s first multi indication CE and ETL certified medical laser

January 28, 2015 by Anca Guina
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Tampere, January 28, 2015 – Modulight, Inc., a leading biomedical laser manufacturer announced today ML7710 laser platform launch and certification. Unlike other lasers in the industry Modulight ML7710 has been certified and supports a wide range of indications and configurations. Medical CE and ETL marking are valid for all multi-channel (1–8 outputs) laser configurations between 400–2000nm and up to 15W vs. typical application and wavelength specific support. ML7710 supports directly several laser based treatment modalities, like photodynamic therapy (PDT), laser surgery, photo disinfection, and photo coagulation. This saves Continue reading →

Modulight ML7710-PDT laser platform CB testing completed

September 9, 2014 by Anca Guina
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Tampere, Finland, September 09, 2014 – Modulight, Inc., an ISO13485 certified laser manufacturer based in Tampere, Finland and San Jose CA, announced today a landmark in medical laser technology. For the first time medical companies can purchase a multi-wavelength turnkey laser system with all design and hardware documentation ready for CE certification or FDA approval through PMA or 510(k) process. The CB certified laser system is also offered as a private label turnkey solution with a possibility for customized treatment protocols. ML7710-PDT product platform has been certified against Continue reading →

Workshop on photodynamic therapy

June 18, 2014 by Modulight
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Sat 7th Feb 5.30–9 pm Downtown San Francisco Topics • Discuss possible ways for enhancing the dissemination of PDT for cancer therapy – Prof. Gal Shafirstein, Roswell Park CI • Scope of active clinical studies in PDT – Prof. Keith Cengel, Univ. of Pennsylvania • Diagnosis, fluorescence and spectroscopy – Prof. Brian Pogue, Dartmouth College • Is dose planning enough or should we use online treatment monitoring? – Prof. Timothy Zhu, Univ. of Pennsylvania • Will multiple channel and/or multiple wavelength lasers make our life easier? – Dr. Timothy Baran, Continue reading →Sat 7th Feb 5.30–9 pm Downtown San Francisco Topics • Discuss possible ways for enhancing the dissemination of PDT for cancer therapy – Prof. Gal Shafirstein, Roswell Park CI • Scope of active clinical studies in PDT – Prof. Keith Cengel, Univ. of Pennsylvania • Diagnosis, fluorescence and spectroscopy – Prof. Brian Pogue, Dartmouth College • Is dose planning enough or should we use online treatment monitoring? – Prof. Timothy Zhu, Univ. of Pennsylvania • Will multiple channel and/or multiple wavelength lasers make our life easier? – Dr. Timothy Baran, Continue reading →

Workshop on the best practices in clinical photodynamic therapy

June 18, 2014 by Modulight
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Fri 24th April 6 pm, Gaylord Palms Resort, Kissimmee, FL Workshop presentations Products and accessories on display • ML7710 – CE and ETL marked multi-purpose PDT laser platform • ML6700 – PDT-Illumination laser module tailored to PDT for R&D • ML6600 – Multi-wavelength laser module for PDT • External dose calibration module for PDT lasers NEW • Hand pieces for superficial PDT illumination NEW • Tailored PC software for PDT laser modules Speakers’ biographies   Click here to view our previous workshop at PW-2015. Related products: ML7710 – the tool for professionals »   |   Continue reading →Fri 24th April 6 pm, Gaylord Palms Resort, Kissimmee, FL Workshop presentations PDT dosimetry – Dr. Gal Shafirstein, Roswell Park Cancer Center, Buffalo, NY [embeddoc url=”https://modulight.com/wp-content/uploads/2015/08/ASMLS-2015-PDT-Workshop-Prof.-Shafirstein-Final.pptx” width=”280px” height=”210px” download=”all” viewer=”microsoft”] Head & Neck – Dr. Merrill Biel, University of Minnesota Medical School, Minneapolis, MN Cholangiocarsinoma & Esophageal – Dr. Herbert C. Wolfsen, Mayo Clinic, Jacksonville, FL [embeddoc url=”https://modulight.com/wp-content/uploads/2015/08/ASLMS_2015_Jones-Wolfsen.pptx” width=”280px” height=”210px” download=”all” viewer=”microsoft] Thoracic PDT – Dr. Patrick Ross Jr, The Ohio State University, Columbus, OH Mesothelioma – Dr. Keith Cengel, Perelman School of Medicine, Philadelphia, PA Breast – Continue reading →

Medical laser system ML7710 – Tool for professionals

June 18, 2014 by Modulight
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ML7710Laser Platform for Clinical UseML7710 is the most versatile multichannel, multi-indication and cloud connected medical laser in the world. ML7710 supports all known photosensitizers and user-friendly self-calibration. The treatment flow can be customized for specific needs guaranteeing ultimate patient safety and comfort.Perfect laser for clinical and pre-clinical applications ML7710 is a cloud-connected clinical laser platform, suitable for various medical applications, ranging from photodynamic therapy to fluorescence imaging and photothermal therapy. The system can be equipped with up to eight (8) laser outputs on same or Continue reading →

Modulight receives a contract for manufacturing CE certified medical laser systems for cancer therapy

April 17, 2012 by Anca Guina
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Tampere, Finland Apr 17th 2012 – Modulight, Inc., an ISO13485:2003 certified laser manufacturer based in Tampere, Finland and San Jose, CA, announced today that it has successfully designed, integrated and CE certified an OEM medical laser system for PCI Biotech® in Oslo, Norway, for a novel cancer therapy process. PCI Biotech® has developed a unique and patented photochemical drug delivery technology, called PCI (PhotoChemical Internalisation), for use in cancer therapy and other diseases. For this purpose, Modulight delivered a CE certified 7-channel medical laser system solution Continue reading →

Modulight receives ISO 13485:2003 certification for medical laser manufacturing

October 6, 2011 by Anca Guina
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Tampere, Finland, Oct 6th 2011 – Modulight, Inc. based in Tampere, Finland and San Jose, CA, announced the company has received ISO 13485:2003 certification from Det Norske Veritas (DNV). ISO 13485 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of medical devices. The new registration comes as an addition to ISO 9001:2008 and ISO 14001:2004 certifications received by Modulight in 2002 and 2004, respectively. It assures that the company has the fundamental Continue reading →

Modulight gets ISO14001 certification

July 2, 2003 by Seppo Orsila
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Tampere, Finland, July 2nd, 2003 – Modulight, Inc., a manufacturer of high- performance optical semiconductor components, today announced that it has successfully certified its ISO14001 environmental management system. “Environmental management system is fully integrated in the quality management system and it works very well. Environmental aspects have been identified and relevant programs developed for the significant ones. General awareness on environmental issues and related corporate responsibilities is high.” says Ms. Elina Selin, lead auditor from BVQI which continues as Modulight’s audit partner. “We have built the Continue reading →