ISO 13485 – Certification for Medical Device Manufacturers

A Quality Management System

Medical Symbol
The ISO 13485 standard is for manufacturers of medical devices or medical device components. Due to the vital nature of products manufactured for medical use, product conformity of medical devices is paramount. The global acceptance of ISO 13485:2016 helps safeguard product conformity as manufacturing supply chains have expanded nationally and internationally. For an overview of ISO 13485 download the free information sheet.
The processes for design and manufacturing of medical devices is the subject of this standard. It references the ISO 9001:2008 standard with extensive additions pertaining to more stringent controls applicable to such sensitive products. In many countries, statutory and regulatory requirements are based on the ISO 9001 and ISO 13485 standards. An example is the U.S. revised Quality System Regulation (FDA 21 CFR 820) which in large part incorporates these two ISO international standards. Also, ISO 13485:2016 certification is commonly an initial step for medical device manufacturers seeking compliance with the requirements of the Medical Device Directive (MDD) and the CE marking process in the European Union (EU).

ISO 13485 Certification Benefits

Small businesses may gain a number of benefits from an ISO 13485:2016 certification:

  • Foundation for establishing compliance with FDA, MDD or CE requirements
  • Ensure QMS practices that produce consistently safe and effective medical devices
  • Helps you manage risk effectively
  • Provides for the opportunity to improve QMS processes and efficiencies
  • Creates opportunities to gain new business within medical device industries
  • Essential controls to ensure product conformity and regulatory compliance

The new ISO 13485 emphasizes risk management and risk-based decision making for processes outside the realm of product realization. The focus is on safety and performance of medical devices and compliance with regulatory requirements.

The ISO 13485 is a stand-alone standard. It is similar in scope and intent to ISO 9001.

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Consulting Support for ISO 13485

Core Business Solutions has qualified ISO 13485 consultants ready to help you achieve certification. Support for the ISO 13485 standard is available through all of our Online and Onsite Consulting Programs. We also provide consulting support for companies seeking multiple certifications.

Our consultants translate the technical language of the standard into Plain English and make it as simple and effective for your organization as possible. Implemented properly, ISO 13485 gives you a continual return on your investment.

For more information about ISO certification for the 13485 standard, please call our consulting office at 866-354-0300, or email

Related standards

  • See ISO 9001 for quality management systems
  • See ISO 14001 for environmental management systems
  • See ISO 45001 for health and safety management systems
  • See AS9100 for aerospace manufacturers

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