ISO 13485
Medical Device Quality Management System
What is it?
It is a quality system standard meant for medical device manufacturers and suppliers. It covers several elements like Quality Management System, Management Responsibility, Resource Management, Design Control, Product Realization, and Measurement, Analysis and Improvement. Getting an ISO 13485 certification is essential to comply with regulatory requirements from authorities all over the world (Europe, Australia, Japan, Korea, Brazil, Singapore and Malaysia etc).
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It is also a common requirement imposed Manufacturers on their Original Equipment Manufacturers (OEM) and/or suppliers.
Benefits of Getting ISO 13485 Certification
The most significant benefit of having certification to the global standard – ISO 13485 Medical Device Quality Management Systems is market access. In most countries, the lack of this certification means that the company cannot operate in the medical devices industry.
Companies with the ISO 13485 certification can also:
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Meet client requirements and increasing customer satisfaction through quality processes, meeting product specifications, and maintaining brand reputation
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Comply with all applicable statutory and regulatory obligations;
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Address product needs, quality, and safety without losing sight of business operations.
We provide these additional services to maintain ISO 13485 Certification
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Conduct internal audit
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Conduct audit to critical supplier
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Support external certification/surveillance audit
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Conduct gap analysis and closure on QMS
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Provide regulatory strategy report
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Ad Hoc Consultancy on Quality, Risk Management & Regulatory
