ISO 13485
ISO 13485 is a standard that represents a set of quality management system requirements for any company involved in the design, production, installation, maintenance and manufacture of medical devices.
The purpose of these requirements is to ensure that medical devices and services meet customer expectations and relevant regulatory requirements.
Why implement it?
- Adoption of an adequate model for the implementation, monitoring and revision of all personal identity information in the Quality Management System;
- Prove software compliance with legal and regulatory requirements, as well as the needs of customers and end users;
- Ensure the effectiveness and safety of both the processes and the products delivered.
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- Identify risks in your work environment
- Organize and systematize tasks
- Guide and empower your team
ISO 13485 includes requirements for design and development, risk management, production and post-production processes for medical device companies.
How we perform.
Benefits
What are the benefits for your company?
Progress
Creating a solid foundation for growth and expansion of operations into new markets
Monetization
Reduced waste, rework and other inefficiencies
Efficiency
Process optimization makes organizations more efficient
Trust
Delivery of safe medical devices that meet customer requirements
Learn how to improve the quality management system in medical devices.
- What you will find in this ebook:
- A clear and objective introduction to the medical devices quality management standard
- Answers to the most frequently asked questions
- Benefits and advantages of the standard's certification