…that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices.” The agency also concludes that most comments, complaints and adverse events (including deaths)…
…that many OEMs and third party entities provide high quality, safe, and effective servicing of medical devices.” The agency also concludes that most comments, complaints and adverse events (including deaths)…
In the United States, the company has recalled nearly 360,000 AirLife Resuscitation Device and Broselow Convenience Kits due to a malfunction risk….
In the United States, the company has recalled nearly 360,000 AirLife Resuscitation Device and Broselow Convenience Kits due to a malfunction risk….
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Dexcowin Co. Ltd.,…
…managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (February 2018). Inspections, Compliance, Enforcement, and Criminal Investigations. Dexcowin Co. Ltd.,…
…function worsening over a number of years, and is more common than acute kidney injury. High blood pressure can damage blood vessels to the kidneys, diabetes can attack kidney tissue,…
…function worsening over a number of years, and is more common than acute kidney injury. High blood pressure can damage blood vessels to the kidneys, diabetes can attack kidney tissue,…
…display emergency exit signage and mount fire extinguishers. Restaurant employees are required to wash hands often and comply with food safety specifications. The healthcare industry is no different—in fact, its…
…display emergency exit signage and mount fire extinguishers. Restaurant employees are required to wash hands often and comply with food safety specifications. The healthcare industry is no different—in fact, its…
…formulate a major share of the overall market. This opportunity has grabbed the attention of in vitro diagnostic (IVD) device manufacturers. Companies are taking efforts to develop and commercialize cost…
…formulate a major share of the overall market. This opportunity has grabbed the attention of in vitro diagnostic (IVD) device manufacturers. Companies are taking efforts to develop and commercialize cost…
…aims to identify principles, premarket review practices and policies for the agency’s regulatory assessment of these types of products and to also provide some application examples. Industry can submit comments…
…aims to identify principles, premarket review practices and policies for the agency’s regulatory assessment of these types of products and to also provide some application examples. Industry can submit comments…
…impact of potential new contracts with customers. Changes in: Revenue Recognition The new FASB revenue standard effective for public companies this year requires medical device companies to comprehensively reassess their…
…impact of potential new contracts with customers. Changes in: Revenue Recognition The new FASB revenue standard effective for public companies this year requires medical device companies to comprehensively reassess their…
…aging population, a growing middle class, and numerous public health campaigns emphasizing preventative care. Foreign manufacturers who want to access this growing market, however, face an extremely complicated regulatory and…
…aging population, a growing middle class, and numerous public health campaigns emphasizing preventative care. Foreign manufacturers who want to access this growing market, however, face an extremely complicated regulatory and…
…be either a polymer, a drug, or a combination, depending on the application. The external sheath is usually a structural, biodegradable polymer. Emulsion electrospinning makes use of a polymer that…
…be either a polymer, a drug, or a combination, depending on the application. The external sheath is usually a structural, biodegradable polymer. Emulsion electrospinning makes use of a polymer that…
