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ISO 13485 Certification For Medical Devices

ISO 13485 certification is essential for medical device organizations that want to demonstrate compliance with regulatory standards (Regional, National & Internation), Following an onsite audit, medical device manufactures will be issued an ISO 13485 certificate by the Notified Body along with CE Certificate.


An MD-QMS, or medical device quality management system, is a collection of policies, processes, documented procedures, and records that must be followed by an organization in accordance with a set of internal rules tailored to the organizational needs of the product or service you provide to customers and patients.

BS/EN/ISO 13485 certification is accepted by various countries. The latest version of the standard followed is (EN) ISO 13485:2016 which was published on 1st March 2016. ISO 13485 standard is structured in a way to assist manufacturers to focus on their system to practice and strengthen its risk management approach and meeting regulatory requirements.

Benefits of EN ISO 13485 Certification

Organizations that have been certified to ISO 13485 will have better control over their processes and the continual improvement possible in all areas of the organization.


The EN ISO 13485 Certification enables the organization for establishing the quality management system in all stages of product realization including medical device design, development, manufacturing/production, servicing, installation, and market surveillance.  The benefits of being an EN ISO 13485 certified organization are the following.

  • Manages the quality of a medical gadget throughout its life cycle.
  • Continuous improvement of medical device product realization processes
  • Ensures medical device safety and continual device improvement.
  • Reduces operational cost and increases the market share.
  • Enhances customer satisfaction.
  • Helps in CE Marking of Medical and In-vitro devices.

Relationship between ISO 14971 & EN ISO 13485 Certification!

The relationship between ISO 13485 and ISO 14791 is that both the standards work together to establish an effective QMS.

ISO 13485:2016 Section 4.1.2 b states that “apply a risk-based approach to the control of the appropriate processes needed for the quality management system”. This organization should adopt a risk-based approach to each and every process that affects the quality.


ISO 13485:2016 (QMS) focuses on the regulatory and customer requirements of medical devices. As a part of this, QMS requires risk analysis to be done keeping ISO 14971 as the guidance document. This means ISO 13485 looks to ISO 14971 for guidelines for the Risk Analysis and implementing the risk control measures and thus to ensure the safety of the device during the product life-cycle.

Relationship between ISO 13485 & ISO 62304 Certification?

ISO 13485 provides the guidelines for the quality management system in the medical device industry. The IEC 62304 provides the requirements for the medical device software development cycle.


IEC 62304, which can be used in conjunction with ISO 13485, offers a platform for the life-cycle processes necessary for the safe design, development, and maintenance of medical device software.


As a basic platform, IEC 62304 assumes that medical device software is developed and maintained within a QMS such as ISO 13485 but does not require an organization to be certified in ISO 13485. Therefore, IEC 62304 can be a software development specific supplement to ISO 13485 standard.

Important steps of EN ISO 13485 Implementation

Not all organizations are the same, some make class I or some make class III devices or some manufacture IVD devices. Implementation of ISO 13485 and requirements different from organization to organization. Generally, following are the major stages of ISO 13485 implementation:

    1. Understanding the standard requirements
    2. Gap Analysis of the current system and with the requirements
    3. Stagewise planning of the QMS establishment
    4. Providing the required training for the QMS team
    5. Documentation of the QMS including the records
    6. Internal Quality Audits and CAPA
    7. Management Review meetings