Yogyakarta Office
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Jalan Dladan No. 98 Tamanan, Banguntapan, Bantul, Daerah Istimewa Yogyakarta 55191
Jakarta Office
Jalan Mampang Prapatan Raya No.73A Lantai 3 Jakarta Selatan 12790
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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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Make this a strategic step to enhance customer trust, unlock new market opportunities, and strengthen your business reputation.
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