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Certifications & Compliance

ISO 13485:2016 Medical Devices Quality Management (MDQMS)

ISO 13485:2016 is the international standard for Quality Management Systems for medical devices. Required for manufacturing of medical equipment worldwide.

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

Transparent Pricing

$7,500

Starting at $7,500 for medical device manufacturers. Price varies by device class and regulatory requirements.

Key Benefits

Why choose our ISO 13485:2016 Medical Devices Quality Management (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.

Ready to Get Started?

Contact us today for a free consultation and customized quote for your ISO 13485:2016 Medical Devices Quality Management (MDQMS) needs.

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