NAMSA, a world leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, announced today its intent to acquire ÅKRN Scientific Consulting, a prominent Euro...
Leer másArtificial intelligence (AI) is constantly bringing improvements to the field of medical devices, with AI technology being embedded in software used as a medical device or being a medical device by it...
Leer másThis article summarizes the guidance document released by the Medical Device Coordinating Group (MDCG 2022-5) to support manufacturers in qualifying borderline products.
Leer másLa demanda de productos sanitarios se encuentra en constante aumento, un nicho de oportunidades donde escasean profesionales y talento para satisfacer las necesidades del sector tecnológico-sanitario...
Leer másWhen considering obtaining an ISO 13485 certificate, developing and implementing a quality management system (QMS) is not the end of the road. Indeed, medical device manufacturers must first ensure th...
Leer másIn vitro diagnostic medical devices (IVDs) are increasingly in demand as the medical technology evolves by leaps and bounds. With the application of the In Vitro Diagnostic Medical Device Regulation (...
Leer másSafety reporting is a crucial aspect of a successful clinical investigation for medical devices. In addition to the Good Clinical Practice (GCP), stakeholders are required to comply with the Medical D...
Leer másPerformance studies for SARS-CoV-2 IVD tests have become a hot topic since the publication of the MDCG 2021-21 and the common list of COVID-19 IVD tests. These two documents have strengthened the requ...
Leer másThe implementation of the Medical Device Regulation (EU) 2017/745 (hereinafter referred to as MDR) has set new requirements for performing clinical investigations. Indeed, whereas the previous directi...
Leer másEveryone involved in clinical research must follow Good Clinical Practice (GCP) as specified in ICH GCP and the international ISO standard 14155:2020, the EU MDR 2017/745, the EU IVDR 2017/746, the EU...
Leer másClinical investigations with medical devices should be performed by health care professionals with scientific and medical qualifications and appropriate experience, preferably in the proposed resea...
Leer másThis article will provide you information on MDCG 2021-21 guidance document and let you know how you can place and keep your SARS-CoV-2 IVD products on the EU market.
Leer más