Therapeutic ultrasound is regularly used in healthcare system with the aim of treatment disease. Considering, the significance of these device in daily activities of medical professionals and impact of their measurements on the health of patients, safety and accuracy of their measurements is becoming ...
administration makes no. 53) requirements, The State Medical Products Administration has organized the revision of the Verification Guide for the Registration Quality Management System of Medical Devices (see the annex), which is hereby issued and shall come into effect as of the date of ...
In order to strengthen the verification management of the medical device registration quality management system and ensure the quality of the verification work, according to the "Regulations on the Supervision and Administration of Medical Devices", "Administrative Measures for Medical Device Registration ...
If you develop products — medical devices, particularly — then you’ve heard the terms and design verification and validation (also called V&V). Here we’ll explain what the two activities are, the difference between them, plus share tips for getting the most out of your efforts. Note: To...
Medical Device Quality Management System Requirements The registration applicant shall, in accordance with the requirements of the Quality Management Practice for the Manufacture of Medical Devices and its appendices, establish a medical device Quality Management System appropriate to the process of product ...
As part of design and development validation, the organization shall perform clinical evaluations or performance evaluations of themedical devicein accordance with applicable regulatory requirements. Validation shall be completed prior to release for use of the product to the customer. ...
Manufacturers of electrical and electronic goods demand reliable verification, testing, and screening technologies for compliance with Worldwide Restriction of Hazardous Substances (RoHS) regulations. An update to RoHS, known ...
For modern medical devices, the sheer weight of documentation generated as part of the requirements gathering, design iteration and verification phase can be overwhelming. Developers can easily lose track of their design decision-making in a tsunami of different documents. Without the right software,...
Cloud-based runtime verification of health-caring systems using software agents Today, the implantable medical devices are increasingly used. According to U.S Food and Drug Administration, the medical devices sale has increased as 56% between 2004 and 2009, while the drug sale has increased only ...
For instance, the International Medical Device Regulators Forum defined ‘Software as a Medical Device (SaMD)’ as a software that performs independently of medical device hardware and that is intended to be used for medical purposes17. Importantly, this regulatory construct means that software (...