Medical Device License Articles & Analysis
16 news found
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U.S. medical device regulations require manufacturers of most class II and a small number of class I devices to file a 510(k) unless they qualify for an exemption. 510(k) is a premarket technical document submitted by the manufacturer to the FDA before the medical device product enters the US market to prove that ...
Our service areas range from chemicals, pharmaceuticals, medical devices, cosmetics, food & dietary supplements to agrochemicals & biocides. Our featured services include but are not limited to FDA Medical Device Registration, 510(k) Premarket Notification, Drug Master File Document, FDA ANDA, FDA NDA, IND Application, ...
Our service areas range from chemicals, pharmaceuticals, medical devices, cosmetics, food & dietary supplements to agrochemicals & biocides. Our featured services include but are not limited to FDA Medical Device Registration, 510(k) Premarket Notification, Drug Master File Document, FDA ANDA, FDA NDA, IND Application, ...
To sum up, Proregulations can offer support in activities like FDA Medical Device Registration, 510(k) Premarket Notification, Drug Master File Document, FDA ANDA, FDA NDA, FDA Cosmetics Registration, New Dietary Ingredients Compliance, Toxic Substances Control Act Compliance, FDA Agent Services, Medical Device Distributor ...
SANUWAVE Health, Inc. (OTCQB:SNWV), a leading provider of next-generation advanced wound care medical systems for the repair and regeneration of skin and vascular structures and the research for new applications for shockwave systems in the non-medical field, announced today the patent activity for the full year 2020 and the first quarter of ...
Spectrum Dynamics Medical, Inc., has received Canadian Medical Device License from Health Canada for its premium digital SPECT/ 64-sliceCT scanner, VERITON-CT64. ...
Until now, patients needing routine or emergent care required transportation by medical charter flight hundreds of miles away to either Timmins or Kingston, ON. ...
“UHF ultrasound, delivered through FUJIFILM VisualSonics’ systems, is the highest resolution medical ultrasound available today. The FUJIFILM VisualSonics’ Vevo® MD, coupled with PIUR IMAGING’s tUS Infinity platform, offers researchers and clinicians the ability to visualize and measure ultrasound volumes in 3D,” said Greg Nesbitt, vice ...
— September 29, 2021 — Sommetrics, a private company developing products and services to improve sleep health, today announced the launch of the pivotal clinical trial of its aerSleep® II device for the treatment of obstructive sleep apnea (OSA). This study is being conducted at 10 university and community-based sleep centers in the U.S. under an Investigational ...
The ExactVu micro-ultrasound system including the FusionVu application have received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)) and Canada (Health Canada medical device license). ...
This significant investment in innovative Canadian technology will strengthen Canada’s position as a leader in the medical technology space.” “While the medical technology sector is growing in Canada and worldwide, innovations are welcomed to overcome challenges of access, availability, and ...
The ExactVu micro-ultrasound system including the FusionVu application has received regulatory approval in the European Union (CE Mark), the United States (FDA 510(k)), and Canada (Health Canada medical device license). ...
Ken Nelson, Chief Commercial Officer added, “Along with our Health Canada Medical Device License, the ability to distribute a CE-marked 14-CAM patch outside of the United States is one more step towards our P-wave centric detection and analysis technology becoming the global standard of care in long-term cardiac ...
Biomatlante, a world leader in synthetic bone regeneration technologies, is pleased to announce the obtention of the MDSAP* accreditation on the new ISO 13485:2016 Certificate. The Medical Device Single Audit Program (MDSAP) is an international program for assessing the quality management systems of medical device manufacturers ...
Proa Medical, Inc. was granted a Device Manufacturing License by the Department of Public Health Food and Drug Branch of the State of California. "Proa Medical has a high commitment to quality and has created a culture of quality that reaches all aspects of its operations," said Proa Chief Operating Officer Afshin Nadershahi. ...