ISO 13485 Certification & Consulting Services
What is ISO 13485 Certification?
ISO 13485:2016 is an internationally recognized standard that defines the requirements for a quality management system (QMS) specific to the medical devices industry. It ensures the consistent design, production, installation, and delivery of safe and effective medical devices.
ISO 13485 is important because it enhances the credibility and compliance of medical device manufacturers by meeting global regulatory and customer requirements.
- Risk Management
- Design control
- Document management
- Corrective and preventive actions (CAPA)
- Regulatory compliance
Cost of ISO 13485 Certification
The cost of ISO 13485 Certification depends on several factors such as the size, complexity, and current quality system of the organization, ensuring it’s tailored to specific business needs.
Builds global recognition and customer trust
Ensures regulatory compliance and quality consistency
Improves product safety and performance
Enhances operational efficiency and risk management
- Maintaining the safety and effectiveness of medical devices
- Achieving consistent quality outcomes
- Ensuring regulatory compliance
- Fostering continuous improvement in quality management systems
Why Choose Qualitcert for ISO 13485 Certification?
Achieve excellence in medical device quality with ISO 13485 Certification Services by Qualitcert. Our expert consultants help organizations implement effective quality management systems that comply with international medical device regulations. Gain customer confidence, ensure safety, and open global market access with our tailored certification support.