ISO 13485 Certification for Medical Device Manufacturers

ISO 13485:2003 is a quality system standard designed specifically for medical device companies, its Benefits of Certification For manufacturers of medical devices who want to provide safe/effective equipment, a proper Quality Management System (QMS) needs to be in place in order to comply with regulatory requirements. The ISO 13485 standard has many of the same requirements as ISO 9001:2008. However, there are additional requirements for process control, design control, retention of records, accountability, traceability, customer feedback and more.

Benefits of ISO 13485 Medical Devices
  • Increase the probability of making safe and effective medical devices
  • Increase access to more markets worldwide with certification
  • Meet regulatory requirements and customer expectations
  • Demonstrate that you produce safer and more effective medical devices
Additional Benefits of ISO 13485 certification:
  • Increased Efficiency
  • Cost Savings
  • More Effective Risk Management and Quality Assurance
  • Improved ability to respond to Customer Requirements

Request Callback

Name :
Mobile :
Email :
Requirement :
Address :
   

Highlights

Hassle Free Certification
We take care of need of client's business requirement. Get ISO Certified for your organization. We offer certification and training for all type of Certifications. Email us at info@internationalcertifications.net.

Best Certification Services
We at, INTL Certification Limited offer quality training on site. Free customer support ease you to get certified today your business.

New Standards
ISO 9001: 2015 Certification, ISO 14001:2015 Certification.