What is ISO 13485:2016

ISO 13485 is the international standard for Medical Device Quality Management System (QMS).

How it works

	ISO 13485:2016 standard takes a process-based approach, guiding you through all stages of a medical device's lifecycle.
	ISO 13485:2016 Medical Device Quality Management System establish a culture of quality throughout your organization.

Who can use

ISO 13485 is designed for any organization involved in the design, development, production, distribution, installation, or servicing of medical devices.

Will ISO 13485:2016 Address my challenges

	Quality and Risk Management
	Lack in Regulatory Compliance
	Cultural Resistance
	Person dependant process flow
	Poor inventory management

Why should I get certified to ISO 13485:2016 Medical Device Quality Management System ?

MDQMS is a powerful tool for Business Improvement and Enhanced Customer Satisfaction. It helps to:

Why ISO 13485

Standardize the organization processes
Build Stronger Reputation
Fewer Regulatory Headaches
Satisfy your customers with timely deliverables
Showcase consistency in quality
Monitor the performances on Product and Process
Efficient supplier management
Identify and manage the risks
Regulate inventorys
Safer Devices

How do I get certified

Our experts will conduct a brief survey to understand your requirements and design a framework for your organization.

	Vision statements
	Goals and Objectives
	Identify risk and opportunities to enhance the business
	Create templates for operations and process flow
	Implement standardized process across levels
	Regular internal audit and management review
	Continuous improvement on quality
	Maintain the process on certification

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