医疗器械法规MDR自我评估表英文版.pdf,Checklist Essential Requirements MDR Essential Principle applicable Evidence Chapter 1 General Requirements Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in
Download an EU MDR checklist today to ensure your medical devices and manufacturing procedures for them are compliant with European standards.
PART 1 TECHNICAL DOCUMENTATION Rationale for the qualification as a medical 1 {填写文件编号} device and the risk class attributed 2 Description and specification {填写文件编号} 3 Technical Specifications of the device {填写文件编号} Information to be supplied by the 4 {填写文件编号} manufacturer ...
根据设备的特性和功能,它可能被分类为活性治疗器械(Active Implantable Medical Device,AIMD)或非主动治疗器械(Non-Active Medical Device,NAMD)等。 确定适用的技术文件:根据设备的分类和风险等级,确定需要准备的技术文件。通常包括技术文件的核心文件(Essential Requirements Checklist),技术文件的详细描述(Device Description...
The template has made it easier to know what information is needed. I have found Advisera's 13485Academy very helpful in providing information for helping me understand what is needed to transition our FDA 21 CFR, Part 820 to also be compliant with ISO 13485:2016. The EU MDR Checklist of...
A survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR).
Checklist for a Secure Remote Audit Recommended measures for your video conferencing system Use a registered account (not a free service) Make sure of latest software version Protect all meetings with a password Chose a service with a “waiting room” option, check-in all participants prior to ...
In order to provide context to the checklist, each table is preceded by a short discussion of changes for that respective chapter in the MDR. The full table is listed in the Appendix. Chapter I – Definitions A significant number of the definitions may or will change, resulting in products...
Start by compiling a checklist of the “Technical Documentation” listed Annex II and Annex III. Most of the documentation listed will already have been generated during steps 1 to 4. However, a few additional items will be required to complete the documentation: ...
内容提示: 1 Form of GENERAL SAFETY AND PERFORMANCE REQUIREMENTS Report Reference NoXXXXX 文件编号 Checklist according to annex I of the Medical Device Directive (MDR EU_2017/745) A/ NA Standards, other directives and other rules applied by manufacturer Documentation (CoAs, protocols, literature or...