ISO 17100 vs ISO 13485 for Medical Device Translation

Introduction

 ISO 17100 and ISO 13485 are globally recognized certifications to ensure accuracy, compliance, and patient safety in medical devices translation.  ISO 17100 sets requirements for how translation services are delivered, including processes, resources and linguist qualifications. ISO 13485 sets requirements for a quality management system for medical devices, and it applies to organizations across the device life cycle.

What Is ISO 17100?

ISO 17100 is the international standard for translation services. Its current edition is ISO 17100:2015. It specifies requirements for the core processes, resources and other aspects needed to deliver a quality translation service.

In practice, it addresses areas such as:

• Qualifications and competence of translators and revisers
• A defined workflow, including translation, a check by the translator and a revision by a second linguist who compares the source and target text
• Project management responsibilities

When buyers discuss ISO 17100 medical translation, they usually mean a medical project delivered through this kind of controlled process. The standard focuses on the translation service itself. It never covers a client’s product, and it never covers every machine translation post editing workflow.

What Is ISO 13485?

ISO 13485 specifies requirements for a quality management system where an organization needs to show it can consistently provide medical devices and related services that meet customer and regulatory requirements. Its current edition is ISO 13485:2016.

The standard applies to organizations involved in one or more stages of the device life cycle, such as design, production, storage, distribution, installation and servicing. Importantly, ISO 13485 is a general standard for medical device quality systems. It contains no requirements written specifically for translation.

ISO 13485 medical devices requirements also carry regulatory weight. The US FDA incorporated ISO 13485:2016 by reference into its Quality Management System Regulation (QMSR), which took effect on February 2, 2026.

ISO 17100 vs ISO 13485 for Medical Device Translation: Key Differences

Both the standards differ on various parameters. Let’s look at some of the differences.

Purpose

• ISO 17100: Defines requirements for delivering a quality translation service.
• ISO 13485: Defines requirements for a quality management system for medical devices.

Scope

• ISO 17100: Covers translation service processes and resources.
• ISO 13485: Covers an organization’s quality management system across the medical device life cycle.

Primary focus

• ISO 17100: Linguist competence, workflow, revision and project control.
• ISO 13485: Documented processes, risk management, supplier control, records and regulatory compliance.

Typical users

• ISO 17100: Translation service providers.
• ISO 13485: Medical device manufacturers and organizations that supply or support them.

Relevance to medical device translation

• ISO 17100: Directly relevant, because it describes how a translation should be produced and reviewed.
• ISO 13485: Relevant to the manufacturer’s quality system and to how it controls suppliers, including translation vendors. 

Which Standard Matters for Medical Device Translation?

Both can matter, and they matter in different ways. ISO 17100 speaks directly to translation service processes. It helps a buyer judge whether a provider works with qualified linguists, independent revision and controlled project steps.

ISO 13485 speaks to the manufacturer’s quality management context. Manufacturers working under this standard are expected to control outsourced processes and evaluate suppliers. A translation service provider can fall within that supplier review when it handles labelling, instructions or other documents that support the device.

Applicability depends on the project, the client, the target market and the regulatory context. No single certificate settles the question. A buyer should look at the provider’s actual workflow and at what the applicable regulations require for the specific documents involved.

Which Medical Device Documents Need Careful Translation?

Many document types need close attention, and requirements vary by market and document type. Common examples include:

• Instructions for use (IFU) translation: Users rely on IFUs for safe operation, so clarity and consistency matter.
• Medical device labelling translation: Labels and packaging carry warnings, symbols, storage conditions and identifiers that must match the approved source.
• Patient facing materials: Leaflets and guides need plain language that remains faithful to the source.
• Clinical and technical documentation: Reports, risk files and technical specifications need precise terminology.
• Regulatory documentation translation: Submissions and supporting files must reflect the approved source content accurately.

Teams planning medical device documentation translation across several markets can explore our medical translation services to see how these document types are handled.

How to Evaluate a Medical Device Translation Provider

A strong translation service provider shows its quality in everyday working practice. Look for these points:

• Subject matter expertise: Linguists who understand medical devices and the specific therapeutic or technical area.
• Qualified linguists: Documented qualifications and relevant experience for each language pair.
• Independent revision: A second linguist who reviews the translation against the source.
• Medical terminology management: Approved glossaries and term bases that keep key terms consistent across documents and updates.
• Translation quality assurance: Defined checks before delivery, such as terminology, number and format verification.

For general guidance on how a structured review workflow supports quality, see our professional translation services page.

Questions to Ask Before Selecting a Provider

Before buying any medical devices, it’s important to clarify and scope our requirements by asking pertinent questions.

1. Which medical device document types and device categories have you translated before?
2. How does your review workflow work, and who revises each translation?
3. How do you build and maintain terminology glossaries for a client?
4. How do you manage version control when source documents change?
5. Which certifications do you hold, and what is the exact scope of each certificate?
6. How do you handle project specific regulatory requirements for each target market?

 Buyers should ask for written answers. Clear, specific replies tell you more than a list of badges.

Frequently Asked Questions

Is ISO 17100 the same as ISO 13485?

No, they cover different processes. ISO 17100 covers translation service processes and resources. ISO 13485 covers quality management systems for medical device organizations.

Does ISO 13485 certify a translation service?

ISO 13485 certification is issued by independent certification bodies to an organization whose quality management system conforms to the standard, within a stated scope. It never certifies an individual translation, and a certificate alone says little about translation quality.

Is ISO 17100 enough for medical device translation?
ISO 17100 describes a sound translation process, but it never guarantees regulatory compliance or error free output by itself.

Which documents may require translation?
IFUs, labels, packaging, patient facing materials, clinical and technical documentation and regulatory submissions may all require translation, depending on the market.

How should buyers verify a provider’s certification scope?
Ask for the certificate, check the issuing body, and read the stated scope and validity dates. Confirm that the scope matches the services you plan to buy.

Conclusion

The medical translation industry is a high-stakes industry that runs on trust and quality. The cost of failing precedes major business decisions. As a result, standardized quality certifications become a non-negotiable as far a medical devices translation is concerned.

ISO 17100 and ISO 13485 serve different purposes. One describes how a translation service should work, and the other describes how a medical device organization should manage quality. Buyers get the best result when they evaluate both the translation workflow and the quality and regulatory requirements that apply to their documents. Clear questions, written answers and verified certificate scopes turn that evaluation into a confident decision.

We at Crystal Hues can discuss your documents, languages and review needs when you request a translation quote.

Sources: ISO 17100 and the FDA QMSR FAQ