Quality
ISO 13485Medical Devices Quality Management System
Qualification and system building towards ISO Medical Devices Quality Management System certification, which sets requirements for designing, manufacturing, supplying and servicing medical devices safely and effectively.
Practical benefits
- Meet medical device regulatory requirements
- Ensure product safety and effectiveness
- Ease registration and market access
- Improve risk management
- Build trust with customers and health authorities
How we work
Your path to readiness, in six stages
A clear sequence from the first conversation to final preparation for the certification or evaluation body.
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Understand
Understand your activity and the required scope.
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Assess
Analyze gaps and evaluate the current situation.
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Develop
Prepare and develop the required documents and procedures.
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Implement
Apply the system and train your team.
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Audit
Conduct the internal audit and address findings.
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Prepare
Final preparation and coordination with the certification or evaluation body.
Project duration is estimated after studying your organization’s size, scope and current readiness.
Talk to a QOM consultant
Tell us about your organization and what you are aiming for. The first consultation is free.