…the act. Compliance for Dummies For this week’s guidance the compliance for dummies will be really brief. Comply baby, just comply! Seriously, if a foreign establishment wishes to enter a…
…the act. Compliance for Dummies For this week’s guidance the compliance for dummies will be really brief. Comply baby, just comply! Seriously, if a foreign establishment wishes to enter a…
…Integra anticipates that if J&J accepts the binding offer it will become a leader in neurosurgical devices, as its portfolio will complement Integra’s line of products for tissue ablation, dural…
…Integra anticipates that if J&J accepts the binding offer it will become a leader in neurosurgical devices, as its portfolio will complement Integra’s line of products for tissue ablation, dural…
Today FDA released an announcement that Zimmer Biomet is recalling its Comprehensive Reverse Shoulder due to a high fracture rate. This device issue can lead to adverse events, including permanent…
Today FDA released an announcement that Zimmer Biomet is recalling its Comprehensive Reverse Shoulder due to a high fracture rate. This device issue can lead to adverse events, including permanent…
The medical device tax went into effect in 2013, but its impact was felt even earlier, as device companies prepared for the 2.3% excise tax via widespread layoffs. And although…
The medical device tax went into effect in 2013, but its impact was felt even earlier, as device companies prepared for the 2.3% excise tax via widespread layoffs. And although…
…large medical company are paid more than $200,000 per year in China. Senior clinical trial professionals that speak English with 10 years of experience at a large foreign medical company…
…large medical company are paid more than $200,000 per year in China. Senior clinical trial professionals that speak English with 10 years of experience at a large foreign medical company…
…widespread in the standards community, and certainly, there are many types of risk. However, the different risks being considered and addressed by various stakeholders can create regulatory problems if it…
…widespread in the standards community, and certainly, there are many types of risk. However, the different risks being considered and addressed by various stakeholders can create regulatory problems if it…
Today Allergan announced its intention to acquire California-based medical aesthetics company Zeltiq Aesthetics, Inc. Zeltiq manufactures products that use its patented cooling technology, most notably the CoolSculpting System, which is…
Today Allergan announced its intention to acquire California-based medical aesthetics company Zeltiq Aesthetics, Inc. Zeltiq manufactures products that use its patented cooling technology, most notably the CoolSculpting System, which is…
…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (January 2017). Inspections, Compliance, Enforcement, and Criminal Investigations….
…Devine guidance for managing key attributes of a FDA-compliant quality management system – 21 CFR, Part 820 Compliance. Charleston, SC: Amazon. FDA. (January 2017). Inspections, Compliance, Enforcement, and Criminal Investigations….
…the fundamental considerations during remediation. MedTech Intelligence: What key points should device companies consider during remediation? Mark Leimbeck: Infrastructure If your company needs to generate information for legacy devices, you…
…the fundamental considerations during remediation. MedTech Intelligence: What key points should device companies consider during remediation? Mark Leimbeck: Infrastructure If your company needs to generate information for legacy devices, you…
Breast cancer is the most commonly diagnosed type of cancer and the second leading cause of death among women, as evident from stats revealed by the National Breast Cancer Foundation….
Breast cancer is the most commonly diagnosed type of cancer and the second leading cause of death among women, as evident from stats revealed by the National Breast Cancer Foundation….
