Implement a QMS for medical devices compliant with ISO 13845.
Implement ISO 13485 and EU MDR simultaneously.
Implement an ISO 13485 & EU MDR consulting job using white label documentation templates.
Straightforward, yet detailed explanation of ISO 13485.
Easy-to-understand explanation of the European Union Medical Device Regulation.
For beginners: Learn the structure of the standard and steps in the implementation.
For consultants: Learn how to run implementation projects.
Download free white papers, checklists, templates, and diagrams.
Free webinars on ISO 13485 and EU MDR delivered by leading experts.
Access the ISO 13485 Gap Analysis Tool and the full text of EU MDR.
Experienced ISO 13485 auditors, trainers, and consultants ready to assist you in your implementation.
We make standards & regulations easy to understand, and simple to implement.
Ask any questions about the implementation, documentation, certification, training, etc.