MDR, IVDR and MDSW Technical Documentation: How to Structure and Maintain It in Confluence
The technical documentation for a medical device is sometimes seen as a regulatory file to be finalised before a submission
Quality Management
Quality Management
Why Use Confluence to Manage a MedTech QMS?
Confluence is more than a document storage platform. When properly structured, it can provide a connected quality environment in which
Quality Management
Manual QMS or Enterprise eQMS? A Third Option for MedTech Startups
Choosing an eQMS for a MedTech startup is not straightforward. When a startup develops a medical device, it must establish
professional-activities
AZ Biotech Consulting Becomes a Member of the Regulatory Affairs Professionals Society (RAPS)
We are pleased to announce that AZ Biotech Consulting has joined the Regulatory Affairs Professionals Society (RAPS), the world’s largest
Regulatory news
Technical documentation for medical devices (ISO 13485 and MDR)
Technical documentation is a critical requirement for medical device compliance. It is required for ISO 13485, MDR, and IVDR, and
Regulatory news
What is a CAPA in ISO 13485?
CAPA (Corrective and Preventive Action) is a core requirement of ISO 13485. It ensures that quality issues are identified, corrected,
Regulatory news
How to implement ISO 13485 step by step
Implementing ISO 13485 can seem complex, especially for MedTech startups and growing companies. However, with a structured approach, it is