What's Included
Comprehensive solutions tailored to your business needs
Quality Manual Development
Design Control Procedures
Risk Management (ISO 14971)
Complaint Handling Systems
CAPA Process Implementation
Supplier Qualification
regulatory Submission Support
CE Marking Assistance
Key Benefits
Why choose our ISO 13485 MDQMS services
Global Market Access
ISO 13485 is a prerequisite for CE marking and FDA registration for medical devices.
Product Safety
Ensure your medical devices meet essential safety and performance requirements.
Regulatory Compliance
Meet FDA 21 CFR Part 820, EU MDR, and other international medical device regulations.
Frequently Asked Questions
Do we need prior certifications?
ISO 13485 can be standalone. However, many companies combine it with ISO 9001 or ISO 13485 + ISO 14001.
Is this required for selling in the US or EU?
Yes, ISO 13485 is essential for FDA registration (US) and CE marking (EU) of medical devices.