- Globally Recognized Certification
ISO 13485:2016 - Medical Devices Quality Management Systems
ISO 13485:2016 establishes comprehensive quality management requirements specifically for medical device manufacturers, ensuring product safety, regulatory compliance, and consistent performance throughout the product lifecycle.
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What is ISO 13485:2016 Certification?
ISO 13485:2016 is the internationally recognized standard for Quality Management Systems (QMS) tailored exclusively to the medical device industry, covering design, development, production, installation, and servicing of medical devices. It emphasizes risk management, design controls, traceability, and documentation requirements that ensure devices meet safety and performance specifications while complying with global regulatory frameworks including FDA, EU MDR, and other national requirements. This certification demonstrates an organization’s capability to consistently produce medical devices that are safe for their intended use.
The standard requires rigorous validation protocols, sterile processing controls where applicable, post-market surveillance, and comprehensive complaint handling procedures to protect patient safety. Organizations certified under ISO 13485:2016 prove their commitment to quality excellence in medical device manufacturing, facilitating market access across multiple jurisdictions, satisfying regulatory audits, and building confidence with healthcare providers, patients, and regulatory authorities worldwide.
- Benifits
Key Benefits of ISO 13485:2016 Certification
ISO 13485:2016 ensures regulatory compliance, enables global market access, enhances product safety, and streamlines approval processes.
Global Regulatory Compliance
Harmonized quality requirements satisfy FDA, EU MDR, and international regulatory standards, simplifying multi-country approvals and registrations.
Enhanced Market Access
Certification opens doors to global markets, meets distributor requirements, and qualifies organizations for government healthcare procurement contracts.
Improved Product Safety
Rigorous risk management and validation processes minimize device failures, adverse events, and patient harm, protecting public health.
Streamlined Regulatory Audits
Comprehensive documentation and established QMS reduce audit complexity, accelerate regulatory inspections, and demonstrate compliance readiness.
- Standard Process
Your Path to ISO Certification
Four straightforward steps to achieve ISO certification: consultation, documentation, payment, and certificate delivery—all managed remotely for your convenience.
Free Consultation
Connect with our ISO experts to discuss your certification needs and requirements.
E-mail Documents
Submit your organization's documents and information securely via email.
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Get ISO Certificate
Receive your internationally recognized ISO certification upon successful audit completion.
- Which Industries?
Who Needs This
Organizations involved in designing, manufacturing, distributing, or servicing medical devices require this certification for regulatory compliance.
Medical Device Manufacturers
Diagnostic Equipment Suppliers
Healthcare Technology Companies
Implant & Prosthetic Producers
- Ongoing Requirements
Compliance & Maintenance
Post-certification, organizations must fulfill ongoing requirements including annual surveillance audits, internal reviews, and recertification to maintain their ISO certificate validity.
