ISO 13485: Why it matters for translation agencies specialising in medical devices

The International Organization for Standardization (ISO), founded in 1947, is the world’s leading body in the creation of standards that ensure the quality, safety, and efficiency of products and services. In the healthcare and medical devices sector, ISO 13485 sets the requirements for a sector-specific quality management system, ensuring that processes comply with the most stringent international regulations.

What is ISO 13485 and how does it benefit translation agencies?

ISO 13485, initially published in 2003 and updated in 2016, is the international standard that defines the quality management system requirements for manufacturers and service providers related to medical devices.

For a translation agency, adopting this standard implies implementing a management system aligned with the regulatory demands of the healthcare industry, which translates into:

• Document management in accordance with medical-sector requirements
• Rigorous control of processes and suppliers
• Complete traceability of translations and reviews
• Proven qualifications of specialised translators and reviewers

Holding ISO 13485 certification demonstrates that the agency operates under the same quality principles as medical device manufacturers.

Can translation agencies be ISO 13485 certified?

Yes. Although ISO 13485 is primarily intended for manufacturers of healthcare products, it can also be applied to essential providers in the medical sector, such as translation companies specialising in medical devices. These companies manage critical content (manuals, labelling, instructions for use, and regulatory documentation) that must meet safety and compliance requirements in each country.

Obtaining ISO 13485 certification demonstrates that the company applies controlled, traceable, and validated processes, ensuring accurate and reliable translations. As a result, international manufacturers can work with a language partner that strengthens their regulatory compliance and facilitates their global expansion in medical device markets.

How does an ISO 13485 certified agency work?

An ISO 13485 certified translation agency applies a quality management system based on a risk-based approach, traceability, and continuous improvement, fundamental pillars of the medical sector.

In practice, this means that each project is managed with the same rigour as a regulated process, including:

• Assessment of client requirements and source documents
• Allocation of projects to translators specialised in medical terminology and regulations
• Technical and linguistic review by a second qualified professional
• Final quality control and full traceability of the process

This approach ensures the compliance, accuracy, and reliability of every delivered translation.

Benefits of working with an ISO 13485 certified agency

For companies in the medical and healthcare sector, collaborating with an ISO 13485 certified translation agency offers specific advantages in terms of quality, compliance, and reliability.

This certification guarantees that translation processes meet the same international standards applicable to medical devices, ensuring:

• Compliance with MDR and IVDR requirements
• Full traceability of translated documents
• Reduced risk of regulatory or terminological errors
• Enhanced trust in the quality and accuracy of multilingual content

In short, working with an ISO 13485 certified agency means partnering with a provider capable of ensuring the integrity and compliance of your translations in highly regulated environments.

Commitment to quality and regulatory compliance

ISO 13485 defines the foundations for providing services that meet applicable regulatory requirements, ensuring documented, controlled, and audited processes by accredited bodies such as Bureau Veritas.

For companies in the medical, pharmaceutical, or biotechnological fields, working with an ISO 13485 certified agency provides:

• Compliance with European and international market demands
• Validated, auditable, and reproducible processes
• Confidentiality and security in information management
• Reliability in terminology and technical documentation

Recent news

Following a recent review cycle, the ISO 13485 standard will remain unchanged for now, as the technical committee decided not to introduce a new version. No updates are expected before 2030, meaning the 2016 edition remains the valid and internationally recognised framework for quality management in the medical devices sector.

This reaffirmation brings stability and confidence to certified companies, confirming that their existing systems and certifications continue to meet international expectations. In essence, nothing changes: a strong message of continuity, reliability, and ongoing commitment to quality.

Choosing an ISO 13485 certified translation agency is not only a matter of language quality but a guarantee of regulatory compliance and safety for your company.

AbroadLink is ISO 13485, ISO 17100, and ISO 9001 certified — all renewed in 2025 — reaffirming its commitment to excellence, traceability, and quality in translation services for the medical and technical sectors.