Discover BSI Group's medical devices capabilities, offering standards and certifications for medical device safety and performance.
医疗器械(技术评估)规则(Medical Device (Conformity Assessment) Regulations): 这些规则规定了医疗器械的技术评估要求。 医疗器械(通报不良事件和通报)规则(Medical Device (Adverse Event and Medical Device Problem Reporting) Regulations): 这些规则要求制造商和注册人报告医疗器械的不良事件和问题。 医疗器械法规指南:...
Classification: ensure the device is a Class I medical device. Choose Conformity Assessment Route: refer theflow chart below. Compile the Technical File. Declaration of Conformity. Appoint an Authorised Representative. (register with the Competent Authority) ...
the success of the medical care services is largely due to the joint contribution of physician's proficiency and the appropriate use of medicines and medical devices.Thus, medical devices are a key component of the medical practice, and subsequently, medical device safety and efficiency are a prio...
BSI Medical Devices provides quality management reviews and CE certifications for medical device manufacturers around the world, and we can do it for you too.
Conformity assessment is primarily the responsibility of the medical device manufacturer. However, it is done in the context of the established regulatory requirements and both the process and conclusions are subject to further review by the regulatory authority and/or conformity assessment body. In ...
Before placing a medical device on the market, manufacturers shall perform a conformity assessment of a medical device. This process shall be carried out by the manufacturer in accordance with the applicable conformity assessment procedures set out in Annexes IX to XI of the Regulation (EU) 2017/...
IEC 62304, Medical Device Software – Software Life Cycle Processes IEC 62366-1, Medical Devices – Part 1: Application of Usability Engineering to Medical Devices ANSI/CAN/UL 2900-1, the Standard for Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements ...
Our streamlined processes and highly skilled team are geared to ensure an efficient conformity assessment. By meticulously planning and execution in every step of the process, we minimise potential delays. Medical Device Market Approval & Certification Complaints & Appeals Vigilance Independence and ...
To assist you in placing your medical devices onto the EU market, Eurofins E&E has a number of Notified Bodies (NB) who can provide conformity assessment to: Certification for the US & Canada To access the United States (US) and Canadian markets, medical devices or equipment needs to be ce...