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AdvaMed Announces New Board Chair and Medical Imaging Division
…executive director of the new Medical Imaging Technology division. “The future is brighter than ever for the medical imaging companies we served at MITA. Our new home at AdvaMed makes…
…executive director of the new Medical Imaging Technology division. “The future is brighter than ever for the medical imaging companies we served at MITA. Our new home at AdvaMed makes…
FDA Announces New Genetic Metabolic Advisory Committee
The FDA is creating a new advisory committee related to potential treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee will advise the agency on products used for…
The FDA is creating a new advisory committee related to potential treatments for genetic metabolic diseases. The Genetic Metabolic Diseases Advisory Committee will advise the agency on products used for…
5 eSTAR Challenges MedTech Regulatory Teams Must Overcome
…educate and prepare medical device manufacturers, regulatory affairs leaders, and regulatory consultants to effectively transition their processes, resources, and operations to seamlessly adopt the eSTAR as the new submission standard….
…educate and prepare medical device manufacturers, regulatory affairs leaders, and regulatory consultants to effectively transition their processes, resources, and operations to seamlessly adopt the eSTAR as the new submission standard….
Essenvia
Ask the Expert: Digital Continuity – Strategies for Product Recall Resilience
…outline a framework to help practitioners assess the relevance and adequacy of completed V&V activities to establish credibility of a computational model. Intelligent computational modeling can also be extended to…
…outline a framework to help practitioners assess the relevance and adequacy of completed V&V activities to establish credibility of a computational model. Intelligent computational modeling can also be extended to…
From TikTok Trends To Counterfeit Drugs: How Better Labeling Systems Can Help
…companies certainly aren’t immune from dupe culture, either. And what is worrying is the damaging impact they could have on human health and behavior. With newly-launched and/or branded medicines commanding…
…companies certainly aren’t immune from dupe culture, either. And what is worrying is the damaging impact they could have on human health and behavior. With newly-launched and/or branded medicines commanding…
Companion Diagnostics Regulations are Evolving in Asia
…Article 6 (concurrent review on companion diagnostic medical devices and medicine) and Article 7 (clinical performance test, etc.) In the near future, the Korean authorities plan to come out with…
…Article 6 (concurrent review on companion diagnostic medical devices and medicine) and Article 7 (clinical performance test, etc.) In the near future, the Korean authorities plan to come out with…
Preparing for EU MDR Post Market Reporting
…companies who have experience in this field. And they bring us on as project consultants, or they may work with other companies who’ve already gone through this process. Generally, you…
…companies who have experience in this field. And they bring us on as project consultants, or they may work with other companies who’ve already gone through this process. Generally, you…
Medcrypt Appoints Former FDA Officer to Vice President of Services
…role in supporting the company’s clients in all areas of cybersecurity compliance through its services, including: FDA Cybersecurity Filing Readiness Survey: This free assessment for MDMs helps gauge submission readiness…
…role in supporting the company’s clients in all areas of cybersecurity compliance through its services, including: FDA Cybersecurity Filing Readiness Survey: This free assessment for MDMs helps gauge submission readiness…
