ISO 13485:2016

ISO 13485 Certification Agency in India & Middle East

Navigate the complex regulatory landscape of Medical Devices. Achieve compliance with CDSCO (India), SFDA (Saudi), and MDR (Europe) through expert ISO 13485 consultancy.

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Medical Device Quality Management (MDQMS)

The Global Gold Standard for Medical Device Manufacturers.

ISO 13485:2016 specifies the requirements for a Quality Management System (QMS) where an organization must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Unlike ISO 9001, which focuses on "customer satisfaction," ISO 13485 focuses on Safety, Efficacy, and Regulatory Compliance. It is the backbone for regulatory approvals in:

  • Europe: Essential for CE Marking (MDR/IVDR).
  • India: Mandated by CDSCO for certain device classes.
  • Saudi Arabia: Required by SFDA for marketing authorization.
  • UAE: Recognized by MoHAP for device registration.
Medical Lab Assessment

Why ISO 13485 is Critical for Market Access

Without ISO 13485, entering the global medical device market is virtually impossible. It is your passport to international trade and patient trust.

Regulatory Approval

Fast-track your product registration with CDSCO, FDA, SFDA, and Notified Bodies in Europe.

Patient Safety

Systematically manage risks (ISO 14971) to ensure your devices are safe and effective for patients.

Traceability

Implement robust tracking updates from raw material to finished product, essential for recalls and vigilance.

Documentation

Establish a Medical Device File (MDF) and Technical Documentation required by regulators.

Risk Management

Embed risk-based thinking throughout the entire product lifecycle, from design to disposal.

Vendor Qualification

Become a preferred supplier to hospitals and large healthcare chains who demand certified vendors.

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Lifecycle of Certification

IQS supports you through the rigorous documentation and audit process required for ISO 13485.

1. Classification

Determine device class (Class A, B, C, D) and regulatory pathway in your target market.

2. QMS Design

Develop Quality Manual, SOPs, and Risk Management file (ISO 14971).

3. Technical File

Compile Device Master Records (DMR) and Design History Files (DHF).

4. Implementation

Train staff, implemented controls, and conduct process validation (IQ, OQ, PQ).

5. Internal Audit

Rigorous internal checks to identify non-conformities before the external audit.

6. Certification

Stage 1 & Stage 2 audits by an accredited Certification Body (or Notified Body).

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Certification Packages

Tailored solutions for Startups, Importers, and Manufacturers.

Distributors / Importers

For organizations trading medical devices (Storage & Distribution).

  • Timeline 3 - 5 Weeks
  • Focus GDPMDS / Supply Chain
  • Starting Cost $1,200*
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Manufacturers (Class A/B)

For low-risk devices like bandages, hospital furniture, simple instruments.

  • Timeline 2 - 3 Months
  • Focus Production Control
  • Starting Cost $2,500*
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Design & Development

Full scope including R&D for electro-medical or sterile devices.

  • Timeline 4 - 6 Months
  • Focus Design Validation
  • Starting Cost Custom Audit
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Sectors We Cover

Medical Instruments

Surgical tools, diagnostic equipment.

IVD (In-Vitro Diagnostics)

Reagents, calibrators, and kits.

Consumables

Syringes, gloves, wound care.

SaMD (Software)

Software as a Medical Device.

Component Suppliers

PCBs, plastics, and contract manufacturing.

Why Choose IQS?

MDR/IVDR Ready

We help you transition to the new European regulations.

CDSCO Experts

Specialized support for Indian Medical Device Licensing.

Technical Writers

We assist in drafting complex Clinical Evaluation Reports (CERs).

Global Network

Partnerships with major Notified Bodies for faster audits.

Frequently Asked Questions

Yes, under the Medical Device Rules 2017 (India), a Quality Management System compliant with ISO 13485 principles is mandatory for manufacturing licensing (Class A-D) and import licensing.

No. ISO 13485 is a QMS standard. CE Marking is a product certification that requires ISO 13485 *plus* a Technical File review and conformity assessment against the MDR (EU) 2017/745.

SFDA requires a QMS for medical device authorization. ISO 13485 is generally accepted as proof of this quality system, often accompanied by an audit from an SFDA-approved body.

The audit duration depends on the number of employees and complexity of the device. It typically ranges from 2 to 5 days onsite for the Stage 2 audit.

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Navigate medical regulations with ease.

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