Medical Devices lifetime whitepaper This paper provides a practical, informative guidance to assist manufacturers in specifying the lifetime of a medical device based on its design characteristics to meet the regulatory requirements of the MDR. ...
Transition to the EU MDR medical device regulation (EU) 2017/745 with a full scope notified body and the expertise and experience of our technical specialists.
EU017/745MedicaldeviceREV.03.01.91/5CHAPTERI范围和定义CHAPTERIScopeanddefinitionsArticle1主题与范围Article1SubjectmatterandscopeArticle定义ArticleDefinitionsArticle3某些定义的修改Article3AmendmentofcertaindefinitionsArticle4产品监管状态Article4Regulatory
It replaces the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). The MDR aims to strengthen the regulatory framework for medical devices and ensure their safety and effectiveness. It introduces stricter requirements for manufacturers, notified bodies, and ...
Most medical device companies have already invested time and resources in understanding and interpreting the relevant regulations and developing the necessary procedures and documentation. In contrast, it is likely that pharmaceutical regulatory teams will...
Cite Medical Solutions is the leader in EU MDR (medical device regulatory) consulting, high-quality literature search, and post market surveillance systems. Contact today!
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mdXperts based in Wernigerode, Germany and Dublin, Ireland is a regulatory consultancy providing analytical and strategic services to the international medical devices and medical technology market. We support manufacturers and economic operators in the medical device life cycle management, the medical dev...
医疗器械ISO 13485是一项质量管理体系的国际标准，全称为《医疗器械－质量管理体系－要求和指南》（Medical devices - Quality management systems - Requirements for regulatory purposes）。它适用于医疗器械制造商、供应商和相关服务提供商，要求这些组织建立和实施质量管理体系，以确保产品的设计、开发、生产、销售和售后...
Guidance Custom-Made Devices Personalized Medical Devices – Regulatory Pathways (IMDRF) imdrf.org/sites/default Website EMDN EMDN database ec.europa.eu/tools/euda Guidance EMDN FAQ on the European Medical Device Nomenclature (MDCG 2021-12) health.ec.europa.eu/sys Website EUDAMED ‘Restricted’ ...