ISO 13485 - Medical Device Quality Management System

WHAT IS THE ISO 13485 - Medical Device Quality Management System

The International Standard ISO 13485 provides a process based model for a regulated environment with a concept of Plan-Do-Check-Act and is more prescriptive in nature which gives assurance to stakeholders on strong implementation of documented Quality Management System and compliances to applicable National and International Regulatory requirements.


Medical Device(s) includes instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings.

By implementing ISO 13485 , Organization demonstrates its control over highly regulated and safe environment of their facilities directly related to medical device(s) life-cycle, meeting national and international regulatory compliances.

Why ISO 13485 - Medical Device Quality Management System

ISO 13485 certification support organizations to meet the International standard of Products and Service they provide, Benefits of ISO 13485 certification are:

Develops customer faith and customer satisfaction

Enhances the ability of Organization to meet applicable National and International strict regulatory requirements

ISO 13485 is accepted by European Union as basis for CE Marking , proves it as a benchmark standard specially designed for Medical Devices

Continually improve the ability to demonstrate highest level of controls

Helps in minimizing life risk of intended user

Provides confidence to Organization on their own System


We’ll be delighted to quote you for our ISO services.

Please complete the form below and we’ll contact you by the end of the next working day to discuss providing a quote tailored to your needs.