ISO 13485 Certification

Medical Devices – Quality Management System

ISO 13485 certification Genveritas Global

The best ISO 13485 Certification Consultants

Genveritas Global is the International ISO 13485 Certification Consulting Company, offering services in various countries. You can reach Genveritas Global and get guidance on ISO 13485 Certification – MD-QMS.

We do provide end-to-end ISO 13485 Certification Support. Our expertise is ISO 9001, ISO 27001, ISO 14001, ISO 45001, ISO 20000, ISO 13485, ISO 22301, ISO 22000, CE Mark, GMP, GDP, and Other International Certification Services.

ISO 13485 certification Genveritas Global

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Introduction - ISO 13485:2016

About QMS Medical Devices

The International Organization for Standardization is a global non-profit body for setting various global standards for Business management and improvements. It comprises representative standardization organizations from various nations. Established in 1947, the ISO frames and promotes worldwide industrial and commercial standards.

ISO 13485:2016 is the recent version of the Quality Management System standard for medical devices. The ISO 13485 Standard provides requirements for regulatory purposes for any organization that are into the manufacturing, production, design, and development, distribution, or service of any kind of medical device. The Standard is applicable to suppliers of the medical devices and related technical support providers.

Like all ISO Standards, ISO 13485:2016 is written based on a High-Level Structure with the principles of the Deming Cycle [Plan-Do-Act-Check]. The Deming Cycle is the best management tool that ensures the smoother and most effective operations in any organization that minimizes environmental impacts, this makes the ISO 13485:2016 more precisive tool to trust with and to implement for guaranteed success for Businesses and helps organizations to showcase their ability to provide quality services by ensuring the safer medical devices.

Benefits - Medical Devices QMS

Advantages of ISO 13485 Certification

  • INCREASE IN MARKET VALUE

    Complying with the ISO 13485 means committed for the Quality & Safety of Medical Devices, that brings additional recognition to your business hence Market Value

  • Expanded Revenue

    ISO 13485 ensures Continuous Improvements by adopting the techniques that reduce the operating costs through less wastage, efficient production leads to High Profit.

  • New Client Acquisition

    Being ISO 13485 Certified guarantees new business opportunities by demonstrating your commitments towards the quality and safety of products.

  • Customer Satisfaction

    By meeting your Client's requirements improves your credibility and enhances their confidence in your business. This leads to higher Business.

  • Comply with Regulatory Requirements

    Through ISO 13485 Implementation, organizations can align with the requirements of Local, & International regulatory requirements.

Support - MD-QMS

GENVERITAS - ISO 13485 CERTIFICATION CONSULTANTs

Genveritas Technologies is an expert ISO 13485 certification and consulting firm offering ISO 13485 services across 40+ locations irrespective of industry. We give 100% achievement assurance as ISO 13485 Certification Consultants. We are an Approved Service Provider with broad mastery and involvement in all International Quality Certification Standards. We would be glad to help your organization in the ISO 13485 process.

On the off chance that you are thinking, how to get ISO 13485 Certification then you are in safe hands. We give one of the most thorough suites of ISO 13485 consulting services to enable the organizations to design, structure, execute, screen, control, improve and upgrade the board framework. Our ISO 13485 advisors are known for being imaginative, basic, reasonable, and viable bringing about an execution procedure that is worth adding to the business tasks of the association.

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MD-QMS Certification Questions

Frequently Asked Questions - FAQ

ISO 13485 Certification is the International ISO Standard that represents the implemented Medical Devices - Quality Management System of the Company.

The current version of the ISO 13485 Environmental Management System is ISO 13485:2016.

Key Principles of ISO 13485 Certification are,
1. Customer Focus 2. Process Approach (PDCA) 3. Risk-Based Thinking 4. Continual Improvement

To Start with ISO 13485 Certification, Companies have to follow the below steps,

  1. Contact Team Genveritas and get the guidance, training, and implementation Planning.
  2. Implement the ISO 13485 Quality Management Systems.
  3. Submit an application to desired ISO Certification Body.
  4. Get Audited the Implemented MD-QMS.
  5. Receive your ISO 13485 Certificate after a successful Audit.
  6. Maintain the MD-QMS System for surveillance Audits.

ISO 13485:2016 shall apply to all businesses such as Medical Devices Manufacturers, Suppliers, Distributors, and other companies whose operations are related to Medical Devices or Components.

There are no fixed charges of any ISO Certifications. The ISO 13485 Certification cost is calculated purely on the basis of Company Size, Number of Employees, Nature of Business, Operating Locations. ISO 13485 charges also vary based on Certification Body and Accreditation Body. To get best quote for your ISO 13485 Certificate, Speak with our experts at +91 8867 260 270.

The Time required to get ISO 13485 Certification is about 15 Days to 90 Days.
If the System is perfectly implemented, It takes 15 Days to get ISO 13485 Certificate. If the organization has to implement the required system, the process may take a minimum of 60 Days and sometimes goes up to 120 days depends on the organization.

Medical Devices - Quality

ISO 13485 Certification Services

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Ensuring

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