…EU MDR or EU IVDR may continue to be placed on the GB market until either the certificate expires or for five years after the new regulations take effect (July…
…EU MDR or EU IVDR may continue to be placed on the GB market until either the certificate expires or for five years after the new regulations take effect (July…
…that make it easier and faster for medical device companies to complete EU MDR and IVDR notified body submissions. The partnership brings together DistillerSR and the Akra Team’s strategic regulatory…
…that make it easier and faster for medical device companies to complete EU MDR and IVDR notified body submissions. The partnership brings together DistillerSR and the Akra Team’s strategic regulatory…
Download our whitepaper today as we provide the key steps to making a successful MDR transition, as well as some insights on how an enterprise quality management system (eQMS) solution…
Download our whitepaper today as we provide the key steps to making a successful MDR transition, as well as some insights on how an enterprise quality management system (eQMS) solution…
…entitled, Managing CERs and PERS Programmatically to Meet EU Regulatory Requirements, four panelists discussed some of the common evidence hurdles manufacturers face in meeting the EU MDR and IVDR requirements…
…entitled, Managing CERs and PERS Programmatically to Meet EU Regulatory Requirements, four panelists discussed some of the common evidence hurdles manufacturers face in meeting the EU MDR and IVDR requirements…
To exclude hazards to users and patients, manufacturers must test their medical devices for biocompatibility. Biocompatibility tests are required in regulatory acts such as the Medical Device Regulation (MDR, Regulation…
To exclude hazards to users and patients, manufacturers must test their medical devices for biocompatibility. Biocompatibility tests are required in regulatory acts such as the Medical Device Regulation (MDR, Regulation…
Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks),…
Understanding EU MDR and IVDR: The goal of EU MDR and IVDR is to ensure safety by asking manufacturers to provide evidence that their products are safe (disclosing any risks),…
…complying with the postmarket surveillance requirements of EU MDR and IVDR? Lana Feng, Ph.D.: [EU MDR and IVDR present] a new kind of active surveillance of product performance and safety….
…complying with the postmarket surveillance requirements of EU MDR and IVDR? Lana Feng, Ph.D.: [EU MDR and IVDR present] a new kind of active surveillance of product performance and safety….
Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision…
Based on extensive research and expert interviews, this 60-page ebook explores the challenges, costs, and opportunities that EU MDR and IVDR have created. Moreover, it offers a solution and vision…
The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, the first MDR approved devices are now hitting the market….
The Medical Device Regulation (EU) 2017/745 became the applicable EU law on May 26, 2021. After a four-year transition period, the first MDR approved devices are now hitting the market….
…the European Union, the Medical Device Regulation (EU) 2017/745 (also known as MDR) defines the requirements for distributing medical devices within the EU. As far as functional safety is concerned,…
…the European Union, the Medical Device Regulation (EU) 2017/745 (also known as MDR) defines the requirements for distributing medical devices within the EU. As far as functional safety is concerned,…
