ISO 13485:2016 aligns medical device organizations with global regulatory expectations, embedding risk-based controls across the product lifecycle to ensure safety and effectiveness. It improves process rigor, traceability, and supplier oversight, reducing defects, recalls, and costs while speeding approvals and market access. Certification strengthens credibility with regulators, clinicians
ISO 13485:2016 is the globally recognized standard for medical device quality management systems (QMS). Certification demonstrates your organization’s ability to consistently meet regulatory requirements, ensure product safety, and improve patient outcomes. It is critical for manufacturers, suppliers, and distributors seeking access to global healthcare markets.
Compliance with ISO 13485:2016 improves operational efficiency, reduces risks, and builds trust with customers and regulators. It supports risk management, design and development, production, and post-market surveillance for medical devices. Certification also streamlines audits and tender processes for healthcare providers.
International recognition and market access
Enhanced product quality and patient safety
Streamlined regulatory compliance
Reduced operational costs and risks
Increased customer and stakeholder trust
Greater competitiveness in global markets
Medical device manufacturers, suppliers, distributors, and healthcare organizations all benefit from certification.
Contact a trusted ISO consulting firm for gap analysis, implementation, documentation, audit support, and certification.
In many countries, ISO 13485:2016 is required or highly recommended for medical device regulatory approval and market registration.
Certification timelines vary but can take from a few weeks to several months, depending on business size and preparedness.
Costs depend on company size, complexity, and the level of support needed. Accurate quotes are available from certification consultants.
Yes, small and medium-sized companies can achieve certification with tailored consulting support and documentation services.
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