Medical devices are constantly changing and evolving to meet the needs of patients and healthcare professionals. The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2022-6, Guidance on significant changes regarding the transitional...
The De Novo classification process is a risk-based approach for classifying novel medical devices that had previously been automatically placed in Class III, the highest United States device classification. On October 4, 2021, the US Food and Drug Administration (FDA)...
With everything from cars to pacemakers now susceptible to cyberattack, questions about how safe our data is have come to the forefront. The Food and Drug Administration (FDA) is one of the organizations taking these concerns seriously, working to ensure that medical...
If you are a medical device manufacturer, it is crucial to have the necessary recall policies and procedures in place to handle a potential field action quickly and effectively. A product recall can be costly and damaging to a company's reputation, so it's essential...
The FDA's Digital Health Center of Excellence (DHCoE), founded in 2020, is a resource for both industry and the public, intending to accelerate innovation in digital health. Recently, they've been involved in several pilots and activities to promote digital health...
The European Union had recently proposed doing what the medical device industry has been urging for years – delaying the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR) that is slated to replace the current In Vitro...
Ashland MA, February 1, 2022. MEDIcept Inc. announced today that Kim Trautman has been appointed as Managing Director and Vice President of the company. An experienced medical device, IVD, and combination product expert, Trautman worked at the US Food and Drug...
If you are currently selling, or planning to sell, medical devices in the United Kingdom, the clock is ticking for Class III, IIb, IIa, and I devices. As of January 1, 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has mandated that all...
The sobering image on the evening news of dozens of massive container ships waiting off the coast of California is all anyone needs to know about the state of the supply chain today. Nothing is moving. Medical device manufacturing is just one of the many industrial...
The CEO and CFO of SpineFrontier, a Malden, MA-based spinal device manufacturer, were recently indicted in connection with a kickback scheme to bribe surgeons to use their products in exchange for “consulting fees,” according to a statement released by US Attorney for...
Medical devices are constantly changing and evolving to meet the needs of patients and healthcare professionals. The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2022-6, Guidance on significant changes regarding the transitional...
The De Novo classification process is a risk-based approach for classifying novel medical devices that had previously been automatically placed in Class III, the highest United States device classification. On October 4, 2021, the US Food and Drug Administration (FDA)...
EUDAMED is one of the key elements of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR). The European Database for Medical Devices, or EUDAMED, is intended to store and provide...
