…127 Lack of or inadequate process validation: 137 Lack of or inadequate procedures involving purchasing controls: 138 Lack of or inadequate complaint procedures: 269 Lack of inadequate CAPA procedures: 400…
…127 Lack of or inadequate process validation: 137 Lack of or inadequate procedures involving purchasing controls: 138 Lack of or inadequate complaint procedures: 269 Lack of inadequate CAPA procedures: 400…
…attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 2017). ELITech Group B.V. 9/20/17. Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed…
…attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (September 2017). ELITech Group B.V. 9/20/17. Inspections, Compliance, Enforcement, and Criminal Investigations. Accessed…
Today Zimmer Biomet announced the appointment of Bryan C. Hanson as the company’s president and CEO. Hanson was most recently a member of Medtronic’s executive committee and the executive vice…
Today Zimmer Biomet announced the appointment of Bryan C. Hanson as the company’s president and CEO. Hanson was most recently a member of Medtronic’s executive committee and the executive vice…
…many new Asian governments supporting medical device development in a number of areas. These new medical devices, supported by their governments, lead to additional competition for Western medtech manufacturers. Below,…
…many new Asian governments supporting medical device development in a number of areas. These new medical devices, supported by their governments, lead to additional competition for Western medtech manufacturers. Below,…
…policy regarding compliance dates of Class I and unclassified devices, and appropriate use of voluntary consensus standards in premarket submissions for medical devices. Draft guidance priorities include export certificates, the…
…policy regarding compliance dates of Class I and unclassified devices, and appropriate use of voluntary consensus standards in premarket submissions for medical devices. Draft guidance priorities include export certificates, the…
New virtual and in-person workshops will bring together FDA and industry experts and stakeholders on a variety of key issues….
New virtual and in-person workshops will bring together FDA and industry experts and stakeholders on a variety of key issues….
The new administration has been in place for almost a year, but many questions remain unanswered. As health reform continues to be a big concern, 2018 “will be distinguished by…
The new administration has been in place for almost a year, but many questions remain unanswered. As health reform continues to be a big concern, 2018 “will be distinguished by…
…$100 million in cash for the company. “The unique beating-heart repair procedure for mitral valve patients complements Edwards’ comprehensive portfolio of treatments for structural heart disease, and reinforces our commitment…
…$100 million in cash for the company. “The unique beating-heart repair procedure for mitral valve patients complements Edwards’ comprehensive portfolio of treatments for structural heart disease, and reinforces our commitment…
…full frontal attack by Chinese medtech companies. On the regulatory front, on November 8, 2017, new regulations from the Chinese government will help Western medical companies have more success in…
…full frontal attack by Chinese medtech companies. On the regulatory front, on November 8, 2017, new regulations from the Chinese government will help Western medical companies have more success in…
This year cybersecurity and ransomware have been a significant issue across all industries. Now ECRI is alerting the healthcare industry to the potential danger that ransomware and malware pose to…
This year cybersecurity and ransomware have been a significant issue across all industries. Now ECRI is alerting the healthcare industry to the potential danger that ransomware and malware pose to…
