As patients continue to demand increasing control over their healthcare, with this comes a desire for more information generated from devices that they use. In recognition of this changing landscape,…
As patients continue to demand increasing control over their healthcare, with this comes a desire for more information generated from devices that they use. In recognition of this changing landscape,…
…this also comes anticipated employee turnover and “targeted” headcount reduction, but the company also concurrently expects new job creation in certain growth areas. “We are taking these steps to build…
…this also comes anticipated employee turnover and “targeted” headcount reduction, but the company also concurrently expects new job creation in certain growth areas. “We are taking these steps to build…
…atherectomy technology, new technology group 1. As of May 2016, CMS is considering new codes for the coming year codes, which may include: XRG1092 New technology, joints, fusion, vertebral joint…
…atherectomy technology, new technology group 1. As of May 2016, CMS is considering new codes for the coming year codes, which may include: XRG1092 New technology, joints, fusion, vertebral joint…
…bulky, the size of a desk top and quite expensive, costing anything in the region of €100, 000 per unit. It can detect abnormalities but at the present moment, compact,…
…bulky, the size of a desk top and quite expensive, costing anything in the region of €100, 000 per unit. It can detect abnormalities but at the present moment, compact,…
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 12, 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Somnowell, Inc. Accessed May 24, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501557.htm…
…management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 12, 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. Somnowell, Inc. Accessed May 24, 2016. Retrieved from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm501557.htm…
…to use to help determine appropriate categorization for an IDE in which the device will be studied.” Comments on the draft document can be submitted within the next 60 days….
…to use to help determine appropriate categorization for an IDE in which the device will be studied.” Comments on the draft document can be submitted within the next 60 days….
…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2016). Inspections, Compliance, Enforcement, and…
…C. (2013). Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (May 2016). Inspections, Compliance, Enforcement, and…
On June 9, industry experts will gather for a roundtable discussion about the key challenges that medtech companies face in product development. The event, which will be a free webinar,…
On June 9, industry experts will gather for a roundtable discussion about the key challenges that medtech companies face in product development. The event, which will be a free webinar,…
…medical device companies can’t avoid these industry changes and must strategize to improve their margins from a different angle. Here are five ways companies can to just that. 1. Use…
…medical device companies can’t avoid these industry changes and must strategize to improve their margins from a different angle. Here are five ways companies can to just that. 1. Use…
…to obtain clearance for sale on the first try because manufacturers can present regulators will compelling evidence that their device can be used safely and effectively by the intended users….
…to obtain clearance for sale on the first try because manufacturers can present regulators will compelling evidence that their device can be used safely and effectively by the intended users….
