…companies may have the clear understanding of the UDI compliance requirements, they might not have adequate in-house resources to address all the tasks under the rule. Chatwin sat down with…
…companies may have the clear understanding of the UDI compliance requirements, they might not have adequate in-house resources to address all the tasks under the rule. Chatwin sat down with…
…time, they had about $25 million in global sales, 90% of which came from the United States. However, a Japanese trading company saw a big opportunity in the device company’s…
…time, they had about $25 million in global sales, 90% of which came from the United States. However, a Japanese trading company saw a big opportunity in the device company’s…
…at last month’s MedTech Intelligence conference on risk management and risk acceptability. Taylor added that while this concept isn’t written into regulation, “to me, it’s just common sense.” https://youtu.be/tHGZcZU5FJg …
…at last month’s MedTech Intelligence conference on risk management and risk acceptability. Taylor added that while this concept isn’t written into regulation, “to me, it’s just common sense.” https://youtu.be/tHGZcZU5FJg …
…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 10, 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. “Las Vegas Resident Indicted For Running Counterfeit…
…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 10, 2016). Inspections, Compliance, Enforcement, and Criminal Investigations. “Las Vegas Resident Indicted For Running Counterfeit…
…testing services will be combined with Nelson Labs, creating the largest fully integrated sterilization and lab services firm worldwide, according to a press release from Sterigenics. The combined entities will…
…testing services will be combined with Nelson Labs, creating the largest fully integrated sterilization and lab services firm worldwide, according to a press release from Sterigenics. The combined entities will…
…vice president, Medtronic and president of the company’s Cardiac Rhythm and Heart Failure division in a press release. “We are thrilled to be the first to introduce a transcatheter pacemaker…
…vice president, Medtronic and president of the company’s Cardiac Rhythm and Heart Failure division in a press release. “We are thrilled to be the first to introduce a transcatheter pacemaker…
The rapidly evolving world of mHealth has resulted in some ambiguity regarding regulations that apply to apps. To alleviate some of the confusion, the FDA and FCC have collaborated to…
The rapidly evolving world of mHealth has resulted in some ambiguity regarding regulations that apply to apps. To alleviate some of the confusion, the FDA and FCC have collaborated to…
…to Ted Bird, chairman of the board at Israel-based ApiFix, Ltd., a company developing technology to treat AIS. Bird adds that globally, the number of children who have spinal curves…
…to Ted Bird, chairman of the board at Israel-based ApiFix, Ltd., a company developing technology to treat AIS. Bird adds that globally, the number of children who have spinal curves…
FDA is investigating the potential presence of counterfeit raw materials in Boston Scientific’s urogynecologic surgical mesh implants. The agency is unaware of any adverse events related to the products. It…
FDA is investigating the potential presence of counterfeit raw materials in Boston Scientific’s urogynecologic surgical mesh implants. The agency is unaware of any adverse events related to the products. It…
Although the unique device identification (UDI) rule was finalized in September 2013, the compliance rollout period will last several years (based on device classification). To help companies as the rule…
Although the unique device identification (UDI) rule was finalized in September 2013, the compliance rollout period will last several years (based on device classification). To help companies as the rule…
