Question 1

What is ISO 13485?

Accepted Answer

ISO 13485 is the international standard for Quality Management Systems (QMS) in the medical device industry. It ensures organizations meet regulatory requirements and consistently deliver safe, effective medical devices.

Question 2

Why is ISO 13485 important for my business?

Accepted Answer

ISO 13485 certification:
 • Demonstrates compliance with global medical device regulations.
 • Improves product quality and patient safety.
 • Builds trust with regulators, customers, and stakeholders.
 • Opens access to international markets.

Question 3

Who needs ISO 13485 certification?

Accepted Answer

Manufacturers, suppliers, and service providers in the medical device supply chain including design, production, installation, and servicing should implement ISO 13485.

Question 4

What are the key requirements of ISO 13485?

Accepted Answer

The standard focuses on:
 • Risk management throughout the product lifecycle.
 • Regulatory compliance.
 • Documented processes for design, production, and post-market activities.
 • Continual improvement of the QMS.

Question 5

What does ISO 13485 certification involve?

Accepted Answer

The process includes:
 • Gap analysis and planning.
 • Implementing QMS aligned with ISO 13485.
 • Internal audits and management reviews.
 • Certification audit by an accredited body.

Question 6

How long does it take to get ISO 13485 certified?

Accepted Answer

Typically, 4–8 months, depending on your organization’s size, complexity, and readiness.

Question 7

Which regulators recognize ISO 13485?

Accepted Answer

ISO 13485 is widely accepted by major regulators, including:
 • FDA (Food and Drug Administration) – U.S.
 • TGA (Therapeutic Goods Administration) – Australia
 • Health Canada – Canada
 • European Commission (CE Marking) – EU
 • MHRA (Medicines and Healthcare products Regulatory Agency) – UK
 • PMDA (Pharmaceuticals and Medical Devices Agency) – Japan

Question 8

How much does ISO 13485 certification cost?

Accepted Answer

The cost of ISO 13485 certification varies based on your organization's size, complexity, certification scope, and associated consulting and certification body fees. At IntegPro, we provide transparent pricing and customized solutions to meet your needs.

Question 9

Do we need a consultant for ISO 13485?

Accepted Answer

While you can implement ISO 13485 internally, working with IntegPro ensures:
 • Faster implementation.
 • Expert guidance on regulatory compliance.
 • Reduced risk of non-conformities.

Question 10

What should you do after getting certified?

Accepted Answer

After achieving ISO 13485 certification, you need to maintain compliance through regular internal audits, continuous improvement initiatives, and periodic surveillance audits conducted by the certification body.

Question 11

How does ISO 13485 integrate with other standards?

Accepted Answer

ISO 13485 can be integrated with:
 • ISO 9001 (Quality Management)
 • ISO 14971 (Risk Management for Medical Devices)
 • ISO  27001 (Information Security) This creates a comprehensive compliance framework.

Question 12

What kind of support does IntegPro offer?

Accepted Answer

IntegPro provides comprehensive support, including end-to-end ISO 13485 implementation, guidance on regulatory compliance, staff training and awareness programs, and ongoing assistance for audits and system maintenance.

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