Medical Devices Quality

Technology that handles lives,
completed through safety

An essential prerequisite for overseas regulatory approval.
The first step into the global medical market.

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Standard Overview

ISO 13485 is a standard for consistently managing quality and complying with regulatory requirements across the entire process of designing, developing, producing, installing, and servicing medical devices. Based on ISO 9001, it reflects the particular characteristics of the medical device industry (cleanliness, sterilization, traceability, and so on).

Why is it needed?

Because medical devices directly affect human health and life, they are very strictly regulated worldwide. To obtain overseas regulatory approval—such as the EU MDD/MDR, the US FDA, and Canada's CMDCAS—building an ISO 13485 system is an essential prerequisite.

Key Features

Documentation

Requires thorough record management, including the Device Master Record (DMR) and Design History File (DHF).

Risk Management

Manages product-lifecycle risk based on ISO 14971.

Cleanroom Management

Manages contamination control and validation of sterilization processes.

Traceability

Secures traceability for rapid recall in the event of a product issue.

Certification Process

System Planning

Prepare the quality manual and procedures

Product Realization

Design/development and sterilization validation

Operation

Generate integrated GMP/ISO operating records

Certification Audit

Detailed audit of documents and the manufacturing floor

Certification

Qualification to enter the global medical device market

Expected Benefits

CE/FDA

Overseas Approval

A foundation for obtaining overseas regulatory approvals such as the EU CE mark and US FDA

Pass

GMP Exemption

Simplified or waived quality audits when exporting to certain countries

Quality

Quality Assurance

Prevent claims by reducing defect rates and securing product safety

Contract

Contract Requirement

Meet the mandatory requirements of global medical device distribution buyers

Frequently Asked Questions

Can I export medical devices overseas without ISO 13485 certification?

In most major export markets, ISO 13485 is effectively a mandatory requirement. ISO 13485 certification or an equivalent system is required for EU MDR (Medical Device Regulation) conformity assessment, US FDA 510(k) submissions, Canadian CMDCAS registration, and more. Without certification, entering overseas markets is difficult in itself.

How is ISO 13485 different from ISO 9001?

ISO 13485 is a standard built on ISO 9001 with additional special requirements for the medical device industry. Key differences include: (1) emphasis on regulatory compliance, (2) requirements for validation of product realization, (3) sterilization process control, (4) traceability for implantable medical devices, and (5) post-market surveillance. It places greater emphasis on maintenance and control than on continual improvement.

Does ISO 13485 certification exempt me from a GMP inspection?

In some countries, building a QMS based on ISO 13485 is recognized as a basis for simplifying or replacing a GMP audit. Australia's TGA and Health Canada are representative examples. However, this is separate from the GMP conformity recognition of Korea's MFDS, so you must verify domestic and overseas regulatory requirements individually.

How is risk management handled under ISO 13485 certification?

ISO 13485 applies ISO 14971 (Medical Device Risk Management) in conjunction. Starting from the product design stage, it goes through the steps of hazard identification → risk estimation → risk evaluation → risk control → determination of residual-risk acceptability, and documents these in a Risk Management File.

Do Software as a Medical Device (SaMD) companies also need ISO 13485 certification?

Yes. Software as a Medical Device (SaMD)—such as diagnostic apps, AI-based medical software, and clinical decision support systems—is also subject to ISO 13485. Systematizing software development and maintenance processes in conjunction with IEC 62304 (Medical Device Software Life Cycle) is key to obtaining international regulatory approval.

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Technology that handles lives,completed through safety