…If the product is based on well-established predicates or comparable competitor products, the rigor and extent of the DHF could potentially be reduced. Having supported many combination product submissions, I…
…If the product is based on well-established predicates or comparable competitor products, the rigor and extent of the DHF could potentially be reduced. Having supported many combination product submissions, I…
…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Lusys Laboratories, Inc. Accessed October 26, 2015….
…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Lusys Laboratories, Inc. Accessed October 26, 2015….
Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation….
Mainstream media attention catapulted the company to the center of controversy for its finger-prick lab tests. Now FDA has taken issue with the company’s complaint handling and design validation….
…economic growth are relatively stagnant, the market for diabetes intervention is strong. Opportunities for Multi-national Companies in the Asian Diabetes Market Large multi-national companies, such as Medtronic, Lifescan, Bayer and…
…economic growth are relatively stagnant, the market for diabetes intervention is strong. Opportunities for Multi-national Companies in the Asian Diabetes Market Large multi-national companies, such as Medtronic, Lifescan, Bayer and…
…medical devices, stand alone, or proprietary. We are excited to share with you the completion of our latest article “Big Changes for CFDA Software Requirements” written by UL Technical Consultant…
…medical devices, stand alone, or proprietary. We are excited to share with you the completion of our latest article “Big Changes for CFDA Software Requirements” written by UL Technical Consultant…
…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Banyan Medical, LLC. Accessed October 19, 2015….
…FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 30, 2015). Inspections, Compliance, Enforcement, and Criminal Investigations. Banyan Medical, LLC. Accessed October 19, 2015….
“In a company with 80,000 employees, we can’t afford to go to sleep,” said Ger Hill, director of research & technology at the Medtronic Bakken Research Centre (BRC), located in…
“In a company with 80,000 employees, we can’t afford to go to sleep,” said Ger Hill, director of research & technology at the Medtronic Bakken Research Centre (BRC), located in…
…problematic and time consuming especially if the component being developed is of medium to high complexity. Make key decisions before coding Making key design decisions prior to beginning the coding…
…problematic and time consuming especially if the component being developed is of medium to high complexity. Make key decisions before coding Making key design decisions prior to beginning the coding…
The medtech market is expected to experience slow growth over the next five years, according to the recently released report by market research firm Evaluate, “World Preview 2015, Outlook to…
The medtech market is expected to experience slow growth over the next five years, according to the recently released report by market research firm Evaluate, “World Preview 2015, Outlook to…
…820 Compliance. Charleston, SC: Amazon. FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities. (October 2015). FDA News Release. Accessed October 12, 2015. Retrieved from http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm465639.htm…
…820 Compliance. Charleston, SC: Amazon. FDA orders duodenoscope manufacturers to conduct postmarket surveillance studies in health care facilities. (October 2015). FDA News Release. Accessed October 12, 2015. Retrieved from http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm465639.htm…
