The AssurX medical device quality management system integrates core quality processes. It includes complaint management, CAPA, deviations, document control, training management, audit management, and change management. Having a single repository for all quality documents enables users to quickly find the ...
When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, so ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies. ...
ISO15225:2010ENMedicaldevices—Qualitymanagement—Medicaldevicenomenclaturedatastructure是国际标准化组织在2010年发布的一个关于医疗器械质量管理的标准。这个标准提供了医疗器械命名结构的数据结构,旨在帮助医疗器械制造商、监管机构、销售商和使用者之间进行更有效的交流和沟通。
The system is provided with advanced quality management models, conforms to the national Medical Device Production Quality Management Standard and an international Medical Device Quality Management System Standard 134851, is integrated with quality management systems of America and European Union and provides...
When it comes to medical device manufacturing, patient safety greatly depends on the quality and consistency of medical products, so ensuring effectiveness, control and maintenance of your QMS is critical to customers, stakeholders, patients and users, and regulatory agencies. ...
Specification for quality control of medical device production (Trial Implementation) general provisions Article 1 in order to strengthen the supervision and administration of medical device production and standardize the medical equipment production quality management system, this regulation is formulated in ...
Intertek Academy learning helps you understand, implement, and improve your business with management systems and compliance training. Go To Intertek Academy SAHPRA Recognized QMS Certificates Intertek Medical Notified Body AB has registered with SAPHRA in recognition of SWEDAC accredited ISO 13485 certificat...
Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System ...
administrationofmedicaldeviceproductionandstandardize themedicalequipmentproductionqualitymanagementsystem, thisregulationisformulatedinaccordancewiththe regulationsonthesupervisionandadministrationofmedical devicesandrelevantlawsandregulations. Second,thisspecificationisthemedicalequipmentproduction ...
LuminLogic is a fully configurable medical device QMS and regulatory compliance software for complete product lifecycle development.