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Apply for ISO 13485:2016 Registration with www.certificationexpert.in. Starting at

Business

APPLY FOR ISO 13485:2016

ISO 13485:2016 REGISTRATION

All You Need To Know

The ISO 13485:2016 deals with medical devices and its management services. Its goals deals with quality management system for establishing and manufacturing medical devises. The 13485:2016 is the latest revised version of the ISO which was published on 1st March , 2016.

Contact us at certificationexpert.in to help you get your certification quickly and easily. Free free to leave us message at info@certification.in and we will get back to you.

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BENEFITS OF 13485:2016 REGISTRATION

Points to make your decision essay

LESS WASTE

Reducing waste is one of the benefit of he certification. Identifying and then removing the excess, over productive, and scrape waste are the benefits enjoyed with its certification. It also reduces labor hour making it coat saving and the reallocation of the resources provide value added services.

UNIQUE IDENTITY

All are there in the name and brand. Your clients will know you only by your brand. They will identify your products and services with the brand attached to it. Registering your trademark ensures this. It automatically gives your product or service a unique identity, different from others

IMPROVEMENT

It also helps in increasing the efficiency and effectiveness of the organization. This certification provides sestamatic improvement to the organization.

STEPS FOR 13485:2016 REGISTRATION

Five Simple Steps

1

Planing &

Implementing

Design.

2

Meeting 

Requirements.

3

Documents &

Records.

4

Management 

Process

5

Certification.

DOCUMENTS REQUIRED FOR 13485 REGISTRATION

Quick Checklist | Specific Requirement

  • Medical Device File
  • Policy/Objectives
  • Risk Management/ Design
  • Records
  • Audits
  • Corrective/Prevention

FAQ

Most frequent questions and answers

It depends upon the framework of the organisation. If they deal with 13485 standards then they require the certification for proper management.                              

It depends upon the organization. It takes 4 o 6 months for small organization.    

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