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ISO 13485:2016 (MDQMS) – NON IAF

ISO 13485:2016 is an internationally recognized standard for Medical Devices Quality Management System (MDQMS). It specifies requirements for organizations involved in the design, production, installation, and servicing of medical devices and related services. The NON IAF certification is suitable for businesses that require quality compliance and documentation support without mandatory IAF accreditation.

Why ISO 13485:2016 Certification is Important?

Ensures consistent quality in medical device manufacturing
Enhances patient safety and product reliability
Helps comply with regulatory requirements
Improves risk management processes
Builds global credibility and market access

Who Needs ISO 13485:2016 (NON IAF)?

Medical device manufacturers
Medical equipment suppliers
Surgical instrument manufacturers
Medical device distributors
Healthcare product exporters

Benefits of ISO 13485:2016 (NON IAF)

Improved product quality and consistency
Reduced operational risks
Better regulatory compliance
Increased customer confidence
Competitive advantage in domestic & global markets

Required Documents for ISO 13485:2016 (NON IAF)

To obtain ISO 13485:2016 (Medical Devices Quality Management System) – NON IAF certification, an organization must provide essential legal, operational, and quality management documents related to medical device manufacturing, trading, or distribution.

Company Registration Proof

Certificate of Incorporation, Partnership Deed, LLP Agreement, or Proprietorship Registration Certificate.

GST & PAN Details

GST Registration Certificate and PAN Card copy of the organization for compliance and verification purposes.

Office / Factory Address Proof

Electricity bill, rent agreement, property documents, or any valid proof of business premises.

Medical Device Product Details

List of medical devices, product specifications, classification, and intended use details.

Quality Management Documents

Quality Manual, SOPs, Risk Management File, Complaint Handling Procedure, and Internal Audit Records.

Technical & Employee Details

Details of technical staff, quality control personnel, training records, and responsibilities.

📌 After document verification, the organization will undergo documentation review, system implementation, internal audit, and final certification approval as per ISO 13485:2016 requirements.

Prices

ISO 13485:2016 MDQMS Non-IAF Certification

Obtain ISO 13485:2016 Medical Device Quality Management System (Non-IAF) certification to comply with international standards for medical devices

₹ 5,999

✔ MDQMS Audit & Consultation
✔ Documentation Preparation
✔ Process Implementation Guidance
✔ Internal Audit Coordination
✔ Certification Assistance

Frequently Ask Questions (FAQ)

ISO 13485:2016 (Medical Devices QMS) – NON IAF FAQs

ISO 13485:2016 is an international Quality Management System (QMS) standard specifically designed for medical device manufacturers, suppliers, and distributors to ensure product safety and regulatory compliance.

NON IAF certification is issued by non-IAF accredited bodies and is generally suitable for branding, internal process improvement, and basic compliance needs.

Medical device manufacturers, traders, exporters, importers, component suppliers, and healthcare equipment companies should apply for ISO 13485 certification.

It improves product quality, ensures regulatory compliance, enhances customer trust, reduces risks in medical device production, and strengthens market credibility.

The certification process generally takes 5–10 working days, depending on company size, scope of medical devices, and documentation readiness.