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    ISO 13485 Certificate Overview

    ISO 13485 Certificate is important for medical device organizations to wish to demonstrate applicable regulatory requirements so-called law of the land.


    Medical device organizations planning for CE Certification that comply with the MD-QMS will be issued an ISO 13485 certificate by the Notified Body and other organizations by Certification Body after an onsite audit


    Medical Device Quality Management System, which is often referred to as an MD-QMS, is a collection of policies, processes, documented procedures, and records to be followed by an organization in-line with a set of internal rules tailored to organizational needs or product or service you provide to customers and patients.

    EN ISO 13485 Certificate Consultant

    ISO 13485 Certification is the world’s most accepted and followed international QMS standard by the medical device industries. The latest version of the standard followed is (EN) ISO 13485:2016 which was published on 1st March 2016.


    ISO 13485 Certification 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 Certificate

    The organizations that have 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 QMS in all phases of product realization including design & development, production, installation, and post-market surveillance.  The benefits of being an EN ISO 13485 certified organization are the following

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

    Relationship between EN ISO 13485 & ISO 14971 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 Certificate?

    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