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ISO 13485 is a standard for quality management systems in the provision of medical devices and related services. With this standard, relevant organizations can ensure that the production, storage, distribution, installation, servicing, and development of medical devices, as well as related activities, are carried out effectively.
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Ensure Product Quality and Safety
Meet Global Regulatory Requirements
Increase Market and Partner Trust
ISO 13485:2016 establishes strict requirements for production process control, verification, validation, and documentation to ensure products are safe, effective, and meet specifications.
ISO 13485:2016 is globally recognized as a leading standard for the medical device industry, supporting compliance with regulations such as FDA (USA), MDR (EU), and other country-specific requirements.
ISO 13485 certification demonstrates an organization’s commitment to quality, safety, and regulatory compliance, increasing trust among distributors, hospitals, physicians, and patients.
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Trust your ISO certification process to our expert team. We are ready to help from start to finish, ensuring your business gets certified quickly and easily.
Initial stage of identification and planning to begin the ISO certification process.
Detailed planning to meet ISO standard requirements.
We help your team understand ISO standard requirements through training specifically designed for your organization's needs.
Stage of implementing the management system in accordance with the established standard requirements.
Audit process conducted by the organization's internal team as requirement fulfillment and preparation for certification or surveillance audits.
Audit process conducted by independent auditors from official certification bodies. The audit stages include:
After successfully passing the audit, an official ISO certificate will be issued by an accredited certification body. This certificate serves as proof of your organization's commitment to quality, safety, or sustainability according to the applied ISO standards.
ISO certification is valid for 3 years, with annual surveillance audits to ensure your management system continues to operate according to standards. After 3 years, a renewal audit is conducted to renew the certificate.
ISO 13485 is a standard for quality management systems in the provision of medical devices and related services. With this standard, relevant organizations can ensure that the production, storage, distribution, installation, servicing, and development of medical devices, as well as related activities, are carried out effectively.
Initial Audit
1st Surveillance
2nd Surveillance
Recertification
Find answers to questions about Certification by MBO here.
Make this a strategic step to enhance customer trust, unlock new market opportunities, and strengthen your business reputation.
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