Medical Devices Quality Management System

Safe devices... protected lives... guaranteed healthy future

Certifiable Medical Devices Healthcare

Standard Definition

Overview of ISO 13485:2016

ISO 13485:2016 is the global gold standard for medical device quality, ensuring that every medical device you produce carries safety and effectiveness, protects patients' lives, and opens global market doors with confidence and excellence.

Standard Importance

Why is this standard important?

Because the global medical device market is worth $432 billion, and 95% of advanced markets require this standard. System implementation achieves: access to all global markets, 90% reduction in product risks, increased physician and patient trust, improved quality and reliability, avoiding fines and recalls.

Implementation Benefits

Advantages your organization will gain

Access to all global markets without restrictions, 90% reduction in product risks, increased physician and patient trust, improved quality and reliability, avoiding costly fines and recalls, enhanced reputation and credibility, increased revenue and profits

Target Organizations

Who can implement this standard?

Essential for all medical device industry players: medical device manufacturers, medical technology companies, medical software developers, medical service providers, medical device distributors, medical research and development centers.

Implementation Scope

How is the standard implemented within the organization?

The system covers all stages of medical device lifecycle: design and development, manufacturing and production, distribution and marketing, installation and maintenance, post-market surveillance, risk management, document control, training and qualification.

Assdaf Methodology

How we help you qualify and obtain certification

At Assdaf, we believe that every medical device carries the responsibility of saving lives. Our methodology includes: comprehensive assessment of current processes, designing integrated quality system, implementing advanced risk management, developing specialized teams, continuous performance monitoring, continuous improvement.

Certification Benefits

Additional advantages of obtaining certified accreditation

Assdaf your partner in manufacturing hope and protecting lives. We guarantee you produce medical devices with the highest global quality and safety standards. Safe devices, open markets, protected lives, guaranteed future.

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Standard Information

Standard Code ISO 13485:2016

Category Medical & Healthcare Sector Systems

Version 2016

Type Certifiable

Family Medical Devices

Sector Healthcare

Need Additional Help?

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Medical Devices Quality Management System

Standard Definition

Standard Importance

Implementation Benefits

Target Organizations

Implementation Scope

Assdaf Methodology

Certification Benefits

Start Your Certification Journey

Get Custom Quote

Standard Information

Need Additional Help?

Related Standards

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----

Medical Devices Quality Management System

Standard Definition

Standard Importance

Implementation Benefits

Target Organizations

Implementation Scope

Assdaf Methodology

Certification Benefits

Start Your Certification Journey

Get Custom Quote

Standard Information

Need Additional Help?

Related Standards

Medical Laboratory Accreditation

Clinical Investigation of Medical Devices Management

Quality of Pharmaceutical Packaging Materials

Most Popular Standards

Quality Management System

Information Security Management System

Environmental Management System

Occupational Health and Safety Management System

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