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ISO 13485 Certification

What is ISO 13485 Certification?

ISO 13485 is a certification that sets forth the standard of medical devices. Safety and quality assurance is important, especially in the case of medical equipment. To that end, prove that your medical devices fall to the right standards with ISO 13485 certification.

The international standard EN ISO 13485 forms the basis for the certification of quality management systems in companies that manufacture, distribute, and are involved in any life cycle activities of medical devices.

When it comes to medical devices, two things are necessary:

  • The quality of the medical device
  • The safety when you are using such devices

 

Therefore, the regulatory standards for such devices are especially stringent and must be followed through the entire life cycle of the medical device. This is not a matter of the eight qualities; many organizations must demonstrate that they can manage their medical equipment’s quality. This demonstration comes in the form of ISO 13485:2016 certifications.

ISO 13485 sets the standards regarding the quality management system associated with the medical devices industry. If you want this Certification and ISO 13485 guidelines you should get in touch with Operon Strategist, and you can begin applying for the Certification.

Benefits of ISO 13485 Certification

A robust quality management system is fundamental to the operations of a medical device manufacturer, serving as the framework for all activities and tasks. It guarantees that both internal protocols and external regulations are diligently acknowledged and followed.

  • Improves company’s credibility and identity
  • Evidence-based decision making
  • Continual improvement in product process and quality
  • Increased employee involvement.
  • Enhanced customer satisfaction.

Who can apply ISO 13485?

ISO 13485 is specifically designed for organizations involved in the design, development, production, installation, and servicing of medical devices and related services. This includes:

  1. Medical Device Manufacturers: Companies that manufacture medical devices, ranging from small-scale producers to large multinational corporations.
  2. Suppliers and Distributors: Organizations involved in the distribution, supply chain, and logistics of medical devices.
  3. Contract Manufacturers: Companies that provide manufacturing services on behalf of medical device manufacturers.
  4. Service Providers: Organizations offering maintenance, calibration, or repair services for medical devices.
  5. Regulatory Bodies and Notified Bodies: Organizations responsible for regulatory oversight and certification of medical devices.

 

ISO 13485 provides a framework for these organizations to establish and maintain a quality management system (QMS) that meets regulatory requirements and ensures the safety and effectiveness of medical devices throughout their lifecycle.

Eligibility Criteria for ISO 13485 Certification in India

Before applying for ISO 13485 Certification, you must adhere to the points specified in ISO 13485 standards. For that purpose, you need to train your organization as per this standard.

ISO 13485 Certification Requirements

  • Identify and adopt a risk management approach to product development and product realization.
  • Creation of QMS Manual, Processes, Procedures, Formats/Records.
  • Creation of Medical Device Master File.
  • Analysis of the validation of processes and procedures.

What Are the Stages of the ISO 13485 Process?

Following is the process to get an ISO 13485 Certificate:

  1. Creating a Quality System Plan: Planning is the initial stage in every quality system. When discussing how to develop a quality system, the Plan-Do-Check-Act (PDCA) Cycle or the Deming Cycle are frequently used as examples. To deploy modifications to your QMS, you must document the quality plans.
  2. Regulatory Requirements: After choosing your target market for your medical devices, make sure your compliance with other medical device regulations is established. For instance, if you’re creating your quality plan for US medical device firms, you must adhere to 21 CFR part 820.
  3. Documentation, Training, and Records: Your quality system’s process interaction should be defined in your quality manual. The records will provide light on what quality control is testing.
  4. Management Review Process:
    • Conducting Your First Management Review: Doing your management review only after you have finished your full quality system audit and started some corrective actions is advised to ensure that you have inputs for each of the 12 requirements in the ISO 13485:2016 standard.
    • Conducting Your First Internal Audit: The goal of the internal audit is to confirm that the quality system is working as intended and to detect nonconformities before the auditor for the accrediting authority does. The process approach to auditing should be used for internal audits, and the auditor should use a risk-based approach.
    • You will receive an internal audit report from the auditor following your internal audit. Also, you should anticipate the internal auditor’s conclusions and the identification of opportunities for improvement (OFI).
  5. ISO 13485 Certification Audit:
    • To confirm that the quality system has been implemented, the certification authority is required to conduct interviews with process owners and review samples of records. The auditors for the certification body will normally confirm that your business has carried out a comprehensive quality system audit and at least one management review.
    • The Stage 2 ISO 13485 certification audit’s audit objectives particularly call for assessing your quality system’s performance in the following areas:
      • Relevant legal requirements
      • Technologies relating to products and processes
      • Tech support materials

Why to Choose MDR Consultants?

Contacting MDR Consultants for ISO 13485 certification provides specialized expertise tailored to the medical device industry.  Contact us today to discuss your ISO 13485 certification needs and take advantage of our free consultancy session.

Partner with MDR Consultants to achieve regulatory compliance, enhance product quality, and demonstrate commitment to excellence in the medical device industry.

Ready to Take the Next Step in the US Market?

Don’t let regulatory hurdles delay your medical device’s entry into the vital U.S. market. Call MDR Consultants today for a free consultation to discuss your device, understand its specific regulatory needs, and explore how our expert guidance can streamline your FDA 510(k) or PMA journey, ensuring efficient and compliant market access.

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