…makes risk management processes increasingly difficult to perform. It is the way medical device companies are handling their processes today. Challenges of Paper-based Processes Many companies are working with manual…
…makes risk management processes increasingly difficult to perform. It is the way medical device companies are handling their processes today. Challenges of Paper-based Processes Many companies are working with manual…
…restoring the ability to process sound, companies are also seeking new ways to help those with hearing loss communicate. Google’s AI team is currently working on products to translate spoken…
…restoring the ability to process sound, companies are also seeking new ways to help those with hearing loss communicate. Google’s AI team is currently working on products to translate spoken…
…or variance from any or all MDR requirements in certain situations. Manufacturers who wish to request a new exemption, variance, or alternative—or to request a modification to an existing exemption—may…
…or variance from any or all MDR requirements in certain situations. Manufacturers who wish to request a new exemption, variance, or alternative—or to request a modification to an existing exemption—may…
…for AI. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. As part of their…
…for AI. Subscribe to the MedTech Intelligence weekly newsletter to stay up to date on the latest news and information on medical device development and regulation. As part of their…
The FDA has issued two new draft guidances: Content of Human Factors Information in Medical Device Marketing Submissions and Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The “Content of…
The FDA has issued two new draft guidances: Content of Human Factors Information in Medical Device Marketing Submissions and Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. The “Content of…
Legacy devices may have more time to come into compliance with EU Medical Device Regulations (MDR). On December 9, the European Commission’s Medical Device Coordination Group (MDCG) issued the “MDCG…
Legacy devices may have more time to come into compliance with EU Medical Device Regulations (MDR). On December 9, the European Commission’s Medical Device Coordination Group (MDCG) issued the “MDCG…
…end-to-end diagnostic instrumentation. The acquisition expands Veranex’s footprint for product design engineering services across the U.S., with combined company offices now in the Eastern, Central, and Western regions, as well…
…end-to-end diagnostic instrumentation. The acquisition expands Veranex’s footprint for product design engineering services across the U.S., with combined company offices now in the Eastern, Central, and Western regions, as well…
…Requirements for New Plants/Production Lines In the case of a new manufacturing plant, or a new production line within an existing plant, Annex 1 requires that companies apply the latest…
…Requirements for New Plants/Production Lines In the case of a new manufacturing plant, or a new production line within an existing plant, Annex 1 requires that companies apply the latest…
…In July, Balwani was found guilty on 10 counts of wire fraud and two counts of conspiracy to commit wire fraud for misleading investors about the financial health of the…
…In July, Balwani was found guilty on 10 counts of wire fraud and two counts of conspiracy to commit wire fraud for misleading investors about the financial health of the…
…Life Science business sector of Merck KGaA, Darmstadt, Germany and are confident that our expertise in bioprocessing process development will complement the Mobius portfolio and help advance life-enhancing therapeutics,” said…
…Life Science business sector of Merck KGaA, Darmstadt, Germany and are confident that our expertise in bioprocessing process development will complement the Mobius portfolio and help advance life-enhancing therapeutics,” said…
