…In addition, the European Union’s Medical Devices Regulation (MDR) is four times longer than its predecessor, the Medical Device Directive (MDD), and contains a vast amount more safety and data…
…In addition, the European Union’s Medical Devices Regulation (MDR) is four times longer than its predecessor, the Medical Device Directive (MDD), and contains a vast amount more safety and data…
…the necessary follow-up. Supporting EU MDR Approval In recent years, both the U.S. and the EU have begun to recognize the value of RWE in evaluating medical devices—and not just…
…the necessary follow-up. Supporting EU MDR Approval In recent years, both the U.S. and the EU have begun to recognize the value of RWE in evaluating medical devices—and not just…
…addition, the company was able to expand access to the trial. The pulse-ox device kits were shipped across the globe to 24 different countries, including study sites in Europe, Asia,…
…addition, the company was able to expand access to the trial. The pulse-ox device kits were shipped across the globe to 24 different countries, including study sites in Europe, Asia,…
…the US, Canada, Japan, Brazil, and Australia as well as the EU Medical Device Regulations (MDR), are impacting medical device manufacturers. These regulatory changes were introduced to raise product quality…
…the US, Canada, Japan, Brazil, and Australia as well as the EU Medical Device Regulations (MDR), are impacting medical device manufacturers. These regulatory changes were introduced to raise product quality…
…to its Medical Device Reporting (MDR) requirements related to events identified in certain real-world data (RWD) sources, such as medical device registries. The exemptions were granted on a case-by-case basis,…
…to its Medical Device Reporting (MDR) requirements related to events identified in certain real-world data (RWD) sources, such as medical device registries. The exemptions were granted on a case-by-case basis,…
This paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates…
This paper reviews some key aspects of safety and performance assessments of AI medical device software according to the existing regulation (EU) 2017/745 (MDR) ahead of the upcoming regulatory updates…
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…
In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new…
In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new…
…MedTech manufacturers and developers, beyond gaining regulatory approval. How did EU MDR impact the development of the Giotto Compliance platform? Palma: EU MDR started to become a hot topic as…
…MedTech manufacturers and developers, beyond gaining regulatory approval. How did EU MDR impact the development of the Giotto Compliance platform? Palma: EU MDR started to become a hot topic as…
…USA, new products reach Europe with a delay, at best.” In addition to challenges brought by new EU MDR, Switzerland has struggled to approve and introduce new devices due to…
…USA, new products reach Europe with a delay, at best.” In addition to challenges brought by new EU MDR, Switzerland has struggled to approve and introduce new devices due to…
