SweetSpot Diabetes Care, Inc. Registers SweetSpot Data Transfer Service as a ...
With the SweetSpot Diabetes Device Data Transfer service, researchers control the transfer of data from patient diabetes devices to research tools and databases according to their own research workflows. SweetSpot's service handles transferring, converting and displaying the data as well as storing it for future use.
SweetSpot's service is web-based, allowing researchers to use the system from Windows and Mac personal computers. Patient devices from numerous manufacturers are supported and devices can be connected to the system from homes or clinics.
By registering their Device Data Transfer service as an MDDS, SweetSpot Diabetes Care, Inc. commits to meeting the reporting and quality system compliance requirements established by the FDA for these systems.
About SweetSpot Diabetes Care, Inc.
SweetSpot Diabetes Care, Inc. Diabetes is a health data company focused on improving the use of data in the treatment of diabetes. SweetSpot specializes in turning raw output from patient devices into powerful information for researchers, health care providers and patients. In clinics or from home SweetSpot performs all data extraction and analysis, relieving frustration with multiple interfaces, drivers and data formats.
Medical Device Quality - News
Washington, DC - Cardiac devices are the most common source of FDA device recalls, a new report from the Government Accountability Office (GAO) has found [1]. What's more, the FDA is not taking full advantage of the data it collects from medical-device
measures including a reduction in the number of headache days per month and improvement in quality of life. This is the largest clinical study to date evaluating the use of PNS via an implanted medical device for the treatment of chronic migraine.
Job Description Our client has an immediate opening for a Quality Engineer to support manufacturing operations for medical devices. Growth in the industry has resulted in the need for an additional member of their quality team. The ideal candidate will
SAN DIEGO, June 24, 2011 /PRNewswire/ -- SweetSpot Diabetes Care, Inc. has registered their Diabetes Device Data Transfer service as a Medical Device Data System (MDDS) with the FDA the Company announced today, while attending the 71st Annual American
But the Hatch report noted that hospitals, physicians and medical device manufacturers would benefit from "clear legal guidance" about PODs, with the "most consistent comment from individuals interviewed by the committee on this topic was 'it was
Memo to the Medical Device Industry: You've Got Problems |
FDA News, a purveyor of U. S. Food and Drug Administration regulatory and international standards compliance newsletters, books, special reports and conferences, gathered the medical devices industry to a come-to-Jesus meeting last week and the warnings were stern: quality has been low and the number of U.S. Food and Drug Administration warnings and recalls is high. Medical device manufacturers haven’t met the bar for quality control and the regulations are about to get a whole lot tighter. Nearly one-third of all medical device recalls occur as a result of design and/or manufacturing defects and root cause analyses shows that there are wide gaps in product design, manufacturing process control, and supplier management. (The FDA can also require a recall based on a wide variety of non-conformance issues including bad record-keeping, failing to report death and injuries associated with a device and failure to establish a corrective action plan.) Experts noted that good adverse outcome data are hard to come by. While the FDA operates a web-accessible complaint database, the Manufacturer and User Facility Device Experience (MAUDE) database, it is hardly complete. MAUDE data consist of voluntary reports made to the FDA since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. (Manufacturers are required to report within 30 days to the FDA any deaths or injuries associated with a medical device they market, regardless of the source.) MAUDE likely only represents a fraction of the complaints actually filed. Most manufacturers still send paper reports, and receive no confirmation from the FDA that the complaint was read or processed, so there’s little confidence that the paper reports get entered into the database. The second take-away from the Eighth Annual Medical Device Quality Congress: Manufacturers must step up their own surveillance of suppliers, because increasingly, the recalls reflect problems created by suppliers, but owned by the manufacturers. The FDA’s Center for Devices and Radiological Health does not inspect or regulate suppliers – the manufacturer is responsible and legally liable for anything their supplier does. Like many industries, medical device manufacturers who look to contain costs by using Asian suppliers are taking risks right now. The standards in that part of the world are antiquated by Western standards, with little oversight.
Plastic Medical Device Quality Engineer / Project Support BaldwinPark Jobs
Massive increase in project in the medical device sector
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