…Unit Our focus is on laparoscopic surgeries. In the U.S., we are approved for general surgery and gynecology. In Europe, we are approved for general surgery, gynecology, neurology and non-cardiac…
…Unit Our focus is on laparoscopic surgeries. In the U.S., we are approved for general surgery and gynecology. In Europe, we are approved for general surgery, gynecology, neurology and non-cardiac…
…Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus…
…Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus…
…For devices on the European market, EU Medical Device Regulation (EU MDR) is designed to ensure public health and patient safety across Europe and to increase quality and transparency of…
…For devices on the European market, EU Medical Device Regulation (EU MDR) is designed to ensure public health and patient safety across Europe and to increase quality and transparency of…
For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work….
For many manufacturers of IVD devices now on the European market, meeting the evidence required of the EU In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) will require tremendous work….
…clinical development and quality assurance services for medtech companies, including an improved ability to navigate EU-MDR/IVDR challenges thanks to Medidee’s experience in the European regulatory space. “Our acquisition of Medidee…
…clinical development and quality assurance services for medtech companies, including an improved ability to navigate EU-MDR/IVDR challenges thanks to Medidee’s experience in the European regulatory space. “Our acquisition of Medidee…
…to evidence-based research in the context of EU MDR compliance and, more specifically for clinical evaluation reports (CER) and performance evaluation reports (PER)? O’Blenis: Literature reviews have always been the…
…to evidence-based research in the context of EU MDR compliance and, more specifically for clinical evaluation reports (CER) and performance evaluation reports (PER)? O’Blenis: Literature reviews have always been the…
…Europe, as a brand owner they could use the address of the U.S. facility. One of the major changes with EU MDR was that the address needs to reflect where…
…Europe, as a brand owner they could use the address of the U.S. facility. One of the major changes with EU MDR was that the address needs to reflect where…
…needed to achieve compliance with the EU Medical Device Regulation (MDR), leveraging equivalence may be a favorable route. In principle, manufacturers can assess risk by comparing similarities and differences between…
…needed to achieve compliance with the EU Medical Device Regulation (MDR), leveraging equivalence may be a favorable route. In principle, manufacturers can assess risk by comparing similarities and differences between…
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and…
Per EU MDR regulations, any medical device on the market must be considered “state-of-the-art.” However, the term is not explicitly defined. Exploring MDR verbiage around standards harmonization, risk management and…
On July 4, The European Commission adopted common specifications for several types of high-risk diagnostics. The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal…
On July 4, The European Commission adopted common specifications for several types of high-risk diagnostics. The specifications set uniform and rigorous benchmarks for tests across the EU, with the goal…
