Filing medical device reports (MDRs) is undesirable and presents a certain amount of risk to the manufacturer. Fortunately, this risk can be ameliorated by approaching event reporting mindfully and ...

近日，时代天使在上海举办MDR-CE证书授证仪式。TÜV南德意志集团 (以下简称"TÜV南德")代表团专程莅临现场，为时代天使正式颁发CE实体证书。此次获得国际权威欧盟公告机构 (Notified ...

The European Union’s Medical Device Regulation (MDR) is a complex regulatory framework created to put in place rules and requirements in how medical devices are designed, manufactured, and marketed.

据介绍，TÜV南德是欧盟官方授权的公告机构，在医疗器械认证领域具有全球公认的专业权威性。本次时代天使所获的MDR-CE证书，是依据欧盟《医疗器械法规》（Medical Device Regulation, ...

In 2006, FDA launched what the agency refers to as a postmarket transformation initiative. Developed through FDA's Center for Devices and Radiological Health (CDRH), the initiative is designed to ...

KIRKLAND, Wash.--(BUSINESS WIRE)--Cardiac Dimensions ®, a leader in the development of innovative, minimally invasive treatment modalities to address patients suffering from heart failure with ...

Pulsecath BV secured a CE mark under the Medical Device Regulation (MDR) for its Ivac 2L system, a percutaneous mechanical circulatory support device, four years after it began the process. “It took ...

DCGI releases classification of 77 medical devices related to oncology: Gireesh Babu, New Delhi Wednesday, January 7, 2026, 08:00 Hrs [IST] As part of its efforts to regulate the ...

The European Council applied its seal of approval to a proposal to extend the deadlines for the Medical Device Regulation (MDR), providing industry some critical breathing room to obtain certification ...

DUBLIN--(BUSINESS WIRE)--The "The Role of the Person Responsible for Regulatory Compliance (PRRC) Under the MDR (Medical Device Regulation) and IVDR (In-Vitro Diagnostic Regulation) Training Course" ...