ISO 13485 Certification

Quality Management System For Medical Devices

ISO 13485 Certification is standard for Quality Management System For Medical Devices. ISO 13485 defines qualifications for a quality management system where an enterprise needs to demonstrate its capability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 13485 Certification

why you need ISO 13485?

Defined Process For Effective Risk Analysis.

User-friendly Approach To Product Development

Improves your company’s credibility and image

Want to know more about ISO 13485?

ISO 13485 defines specifications for a quality management system where an organization needs to demonstrate its capability to provide medical devices and associated services that consistently meet customer and applicable regulatory requirements.

Looking for Certification?

You can send us an email-contact@certease.com and we’ll get in touch shortly, or You Can Call to us- +91 89517 32523
This Is Why

You Should Choose Us

Certified Experts

Quality Services

Affordable Pricing

F.A.Q.

ISO 13485 Certification

ISO 13485 is part of ISO 9001 standard which illustrates its ability to provide medical devices and consistently meet customer and applicable regulatory requirements. Organizations involved in one or more stages including design, development, production, storage, distribution, installation, or servicing of a medical device, provision of associated activities

The cost of an ISO 13485 Certificate varies in accordance with the variety required as per the goods or services dealt with by the business. The cost of ISO 13485 certification further depends upon the circumstances like the size of the business, audit requirements, and level of operations.

ISO 13485 Mandatory Requirements — Documents and Records

  • Monitoring and checking equipment calibration reports.
  • Documents of training, skills, experience, and eligibilities.
  • Product/service specifications review records.
  • Features of product to be produced and service to be presented.
  • Production/service provision change control records.
  • Results of internal audits.
  • Results of the management review.

and more…

ISO 9001 is the international standard that gives specifications for a quality management system that can be implemented to any organization despite the industry, product or service, or company size. ISO 13485 is a comprehensive management system especially for the manufacture of medical devices.

Certease will make the certification process fasters, and simpler. But, it again depends on the size and process of the Organization.

Our Services

Let It Be Any Certification or Audit Service, We Are Here to Help!!

ISO 14001

ISO 14001 is Globally accepted standard for the environmental management in an Institution. 

ISO 9001

ISO 9001 is a Globally accepted standard for a top-quality management system.

GET A FREE CONSULTATION

We assist organizations across the globe by achieving the best methods to get certified into international standards.

Get In Touch
Follow Us

Send us a message

We’ll contact you as earliest as possible