ISO 13485 Certification

ISO 13485 certification maps-out the significance of Quality Management System for Medical Devices. Also, in the highly competitive market rate the organizations struggle being differentiated. Hereby ISO 13485 is an eminent tool for sustaining and nurturing in the market.

Certify your organization to revamp your functioning system. The ISO 13485 certification aids to structure and align your business credibility and authority resulting into overall efficiency of the business.

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We at SIS Certifications look forward to support you in all the possible ways. We are always happy to support you, Starting from the Guidance to understand and choose the relevant standard for your organization till getting certified. Our world class experts and our executive sales team would love to contact you anytime.
We would love to hear from you.
+91-96430 73391, +91-8860610495; support@siscertifications.com

Share your details, We will be Happy to Contact You!


Management system standards such as ISO 13485 is one of the Standard which is also know as the mother of all standards needs to be understood. We at SIS Certifications are well equipped with the experts and trainers who can train you and get you to another level of understanding of the requirements of the standard.
There are various types of ISO 13485 training which you can undergo based on your requirement of level of understanding and need of the standard.
The training can be categorized in to Awareness training, Internal auditor training, lead auditor training and Implementation training.

We would love to hear from you.
+91-96430 73391, +91-8860610495; support@siscertifications.com

Share your details, We will be Happy to Contact You!


Basics

ISO 13485- QMS – Medical Devices is an international standard that defines the requirements for the Quality Management system for the manufacturers, contract services, suppliers, distributors of the medical devices. The major aim of the standard is to maintain harmony between the legal requirements and the management system, the one which is being followed to manufacture or trade the medical devices. The basis for ISO 13485 Certification is ISO 9001 standard and the same is structure is referred and followed for ISO 13485 completion. It is obligatory to implement ISO 13485 Certification for the organizations exporting medical devices to other countries.

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