…of Santa’s workshops; Mr. Claus (upon request) must entertain an inspection from FDA. The good news is that since foreign establishment inspections take some planning on the part of FDA,…
…of Santa’s workshops; Mr. Claus (upon request) must entertain an inspection from FDA. The good news is that since foreign establishment inspections take some planning on the part of FDA,…
…the U.S. medtech industry lost 28,834 jobs—a 7.2% decrease. The majority of job losses were seen in 2014, with the industry losing about 27,000 positions in the industry. https://medtechintelligence.com/news_article/trumps-impact-pricing-rd-funding-cybersecurity-among-top-trends-new-year/…
…the U.S. medtech industry lost 28,834 jobs—a 7.2% decrease. The majority of job losses were seen in 2014, with the industry losing about 27,000 positions in the industry. https://medtechintelligence.com/news_article/trumps-impact-pricing-rd-funding-cybersecurity-among-top-trends-new-year/…
…bombarded with new requests for quotation. The good news is that an establishment’s customer base and the FDA can be placated if all of the complaints are recorded (including verbal…
…bombarded with new requests for quotation. The good news is that an establishment’s customer base and the FDA can be placated if all of the complaints are recorded (including verbal…
…EHR Association backs no FDA regulation for electronic health record systems. Retrieved from http://www.healthcareitnews.com/news/ehr-association-backs-no-fda-regulation-electronic-health-record-systems NiQ Health. (July 30, 2014). Unregulated medical devices used extensively across Australian hospitals. Retrieved from http://www.careplus-niqhealth.com.au/news/niq-health-reveals-the-extensive-use-of-unregulated-medical-devices-in-australian-hospitals.html…
…EHR Association backs no FDA regulation for electronic health record systems. Retrieved from http://www.healthcareitnews.com/news/ehr-association-backs-no-fda-regulation-electronic-health-record-systems NiQ Health. (July 30, 2014). Unregulated medical devices used extensively across Australian hospitals. Retrieved from http://www.careplus-niqhealth.com.au/news/niq-health-reveals-the-extensive-use-of-unregulated-medical-devices-in-australian-hospitals.html…
Medical device cybersecurity is a looming threat that often appears in the news. Hear industry experts discuss design, oversight, risk mitigation and containment at the Medical Device Cybersecurity conference, March…
Medical device cybersecurity is a looming threat that often appears in the news. Hear industry experts discuss design, oversight, risk mitigation and containment at the Medical Device Cybersecurity conference, March…
As if things couldn’t get worse for Theranos, the news came today that the company is cutting nearly 41% of its positions (155 employees), with only 220 staff remaining. According…
As if things couldn’t get worse for Theranos, the news came today that the company is cutting nearly 41% of its positions (155 employees), with only 220 staff remaining. According…
…user, regulatory and business). The higher the risk, the more controls are warranted. This is nothing more than old-fashion common sense, right? There is some good news to share with…
…user, regulatory and business). The higher the risk, the more controls are warranted. This is nothing more than old-fashion common sense, right? There is some good news to share with…
…The good news is creating an audit schedule is left completely in the hands of the establishment. When scripting the annual audit schedule, audits can be planned for and executed…
…The good news is creating an audit schedule is left completely in the hands of the establishment. When scripting the annual audit schedule, audits can be planned for and executed…
…establishment’s approved supplier’s List. The good news is that it is your establishment so you can script requirements for each contractor. If the establishment needs an auditor, then the expectation…
…establishment’s approved supplier’s List. The good news is that it is your establishment so you can script requirements for each contractor. If the establishment needs an auditor, then the expectation…
…for Dummies The good news for device establishments is that most software companies selling COTS into the device industry for document control, CAPA, calibration, etc. also provide appropriate validation tools….
…for Dummies The good news for device establishments is that most software companies selling COTS into the device industry for document control, CAPA, calibration, etc. also provide appropriate validation tools….
