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366 results:
Audits & ISO 13485 Certifications  
Audit: Prerequisite for ISO 13485 Certification In most cases, an audit by a notified body is a prerequisite to market medical devices in the European market. Definitions Definition: Audit „Sy  
FDA  
Overview on FDA related articles FDA Update Q3: End of September with Focus on Software Summary of the summaries You don't have time to study our summaries of the changes to the FDA guidance docum  
Multiple socket-outlets on medical devices  
Multiple socket-outlets on medical devices Naturally, multiple socket-outlets are needed for medical devices in daily practice as well. However, a lot of people are unaware of the regulatory conseq  
The FDA's Safer Technologies Program  
The FDA's Safer Technologies Program With its Safer Technologies Program (STeP), the FDA hopes to open up a new approval pathway for manufacturers of innovative medical devices. The FDA wants patie  
The MDR's Usability Requirements  
The MDR's Usability / Human Factors Requirements Manufacturers must demonstrate compliance with the MDR's usability requirements for all medical devices without exception. For some devices, there  
Market Access of Medical Devices in Brazil  
Market Access of Medical Devices in Brazil Getting medical devices registered in Brazil is not easy. This is partly due to the number of regulations and their complexity and partly due to the fact  
Developing the Wrong Devices with User-Centered Design  
Developing the Wrong Devices with User-Centered Design The aim of user-centered design is to involve users in the development process from the very beginning. As obvious as this approach sounds, it  
Guideline for AI for medical products  
The objective of this guideline is to provide medical device manufacturers and notified bodies instructions and to provide them with a concrete checklist to understand what the expectations of the not  
Instructions for Use & Training Materials  
Instructions for Use & Training Materials We assist you in the process of developing your Instructions for Use (IFU), user manual and training materials. According to the FDA, these materials a  
Recycling and Disposal of Medical Devices: How “Trash” Can Give You a Market Advantage  
Recycling and Disposal of Medical Devices: How “Trash” Can Give You a Market Advantage A lot of manufacturers leave the recycling and disposal of medical devices to operators such as hospitals. But  
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