Tag: "medtech"

...ike to learn more about SoftComply’s apps and Jodocus’ consulting services in compliance, risk management, and document management for MedTech companies in the cloud? Meet us at Medica in D...

• App Central
• Article
• compliance
• document-management
• fda
• mdr
• medical-device
• +3 more tags...

...ignificant challenges in complying with various regulations and their requirements. A MedTech Company must be compliant with their regional safety, performance and security regulations prior to p...

• App Central
• Article
• cybersecurity
• fda
• information-security
• medical-device
• medical-devices
• +10 more tags...

This case study describes the experience of a multinational medical device manufacturer meeting the FDA cybersecurity requirements. The company is operating in the MedTech sector developing a class 2...

• App Central
• Article
• case-study
• cybersecurity
• fda
• medical-device
• medtech
• +4 more tags...

In the Medical Device industry software components, whether standalone or as part of a physical device, must follow the same rules as any other component, i.e. ISO 14971 “Medical devic...

• App Central
• Discussion
• medtech
• risk-analysis
• risk-management
• risk-manager
• softcomply