Which Translation Companies Handle MDR Safety and Clinical Performance Summary Translation
- 1 hour ago
- 6 min read
A summary of safety and clinical performance, the SSCP, has to exist in two versions and in the language of every member state where an implantable or class III device is sold. MDR Article 32 makes it mandatory, the notified body validates it, and it goes public on EUDAMED. Get one language wrong and the record patients and clinicians read is wrong with it.
AD VERBUM is an EU-hosted translation company that pairs a client-tuned LLM with certified medical-device linguists for SSCP work, under ISO 13485, ISO 17100 and ISO 27001. We rank five providers below on the four capabilities that decide an SSCP project. Price isn't one of them, because a cheap summary that fails validation costs far more than the translation.
What an SSCP actually demands
The summary is a public document. It carries the device's intended purpose, its residual risks, and a plain-language account of the clinical evidence, written once for patients and once for healthcare professionals. The MDCG 2019-9 guidance sets the format, and under Decision (EU) 2025/2371 the summary has to stay consistent with EUDAMED, mandatory since 28 May 2026. Four capabilities separate a provider that can carry that load from one that can't:
ISO 13485 and ISO 17100 on the same certificate. The first proves a medical-device quality system with supplier control and traceable records. The second sets translator competence and an independent second-linguist revision. One without the other leaves a gap, which is why ISO 13485 paired with ISO 17100 is the baseline, not a bonus.
SSCP experience across both versions under MDR Article 32, with a validation trail the notified body can follow. The patient version uses lay terms. The professional version keeps clinical register. Same facts, two registers, one terminology base.
Every member-state language the device is placed on the market in, from the 24 EU languages outward. Our breakdown of which MDR documents need translation into all EU languages shows how fast that list grows.
EU-hosted infrastructure and ISO 27001, so clinical and patient data stays inside the EU with no public-cloud detour.
Weighted toward those capabilities, the scorecard reads like this.
Provider | ISO 13485 + ISO 17100 | SSCP, both versions (Art. 32) | Member-state languages | EU-hosted + ISO 27001 |
Yes | Yes | 150+ languages | Yes, EU-hosted | |
Yes, plus ISO 14971 and 18587 | Yes, named | Broad | US-HQ, EU residency contractual | |
ISO 13485 for life sciences | Yes | Broad | UK-HQ, EU residency contractual | |
Yes | Yes | 120+ languages | EU-based; ISO 27001 not listed | |
ISO 17100; 13485 not listed | Yes | Healthcare set | EU-based |
1. AD VERBUM
AD VERBUM meets all four capabilities, which is why we rank first here. We hold ISO 13485 for the device quality system and ISO 17100 for the translation process, backed by ISO 27001, ISO 18587 and ISO 9001. SSCP work runs through our AI+HUMAN workflow: a client-tuned open-weight LLM drafts against your approved term base and glossary governance, then a certified medical linguist reviews every segment for clinical accuracy and the split between the patient and professional versions.
All of it sits on EU-hosted infrastructure with no public-cloud processing, so a summary full of patient risk data never leaves the jurisdiction that governs it. With 3,500+ subject-matter linguists across 150+ languages, we cover every member state a device reaches. The term base we build for the summary carries straight into your EUDAMED device data and the implant card and patient information, so the three stay consistent.
2. TransPerfect
TransPerfect is the largest life-sciences translation company by revenue, and its Medical Device Solutions division certifies to ISO 13485, ISO 14971 and ISO 9001, adds ISO 18587 for AI-assisted translation, and holds ISO 17100 across the group. It names SSCP and SSP work directly and runs MDR content through its EnCompass automation. The boundary for an EU buyer is location. TransPerfect is headquartered in the United States, so EU data residency is a contractual option rather than the default, which matters when the summary carries patient data under GDPR. For scale and device-specific certification, it's a serious choice.
3. RWS
RWS runs ISO 13485-certified translation processes through RWS Life Sciences, with six decades of regulatory and IP work behind it and coverage of IFUs, labelling and regulatory filings. It handles the document types an SSCP sits among and can staff the clinical register. RWS is headquartered in the UK, so like the other non-EU giants it treats EU data residency as a contractual arrangement rather than a default, and its focus is broad enterprise localisation rather than SSCP-first. Strong on life-sciences process. Check where your data will be hosted.
4. Novalins
Novalins is a focused medical and pharmaceutical specialist based in Valencia, certified to ISO 13485, ISO 17100, ISO 9001 and ISO 18587, with around 400 of its linguists carrying clinical, quality or regulatory experience in medical devices. It covers 120+ languages, enough for most EU market footprints. Being EU-based, it keeps work inside the bloc. It doesn't publicly list ISO 27001, so a buyer with a formal information-security requirement should ask how data is controlled. For a mid-scale SSCP programme, it's a credible EU option.
5. MediLingua
MediLingua has done healthcare translation only for more than 30 years, from the Netherlands, certified to ISO 9001, ISO 17100 and ISO 18587, and it keeps the same project manager and linguists on a client's work. It translates SSCPs and the wider device set and can issue translation certificates for submissions. It doesn't publicly list ISO 13485, the device-specific quality standard at the centre of this comparison, so a manufacturer that needs that supplier credential on file should confirm it directly. As an EU boutique for healthcare content, it's a fair shortlist entry.
How to choose in one pass
You can shortlist in a single review. Run each provider against four checks:
Confirm ISO 13485 and ISO 17100 on the same certificate list, not one or the other.
Ask for an SSCP sample that shows the patient and professional versions from one source file.
Check where your data is hosted and processed, not just where the company is registered.
Require the SSCP term base to feed EUDAMED and the implant card, so all three read the same. Our note on MDR and IVDR device documentation covers how that consistency is kept.
The provider that clears all four for your language set is the one to brief.
Our medical device translation services
Our translation services for regulated sectors run on ISO 27001 and ISO 42001 certified, EU-hosted infrastructure, with no reliance on public cloud tooling for core processing. Every project runs through our AI+HUMAN hybrid workflow: we ingest client Translation Memories and Term Bases first, our proprietary LLM-based LangOps System generates output constrained by client terminology on client-tuned open-weight models, and our certified subject-matter experts review for technical accuracy and regulatory compliance. Our QA is aligned to ISO 17100 and ISO 18587, with sector-specific requirements such as ISO 13485 medical-device quality management and MDR Article 32 SSCP validation applied where relevant. We serve Life Sciences, Legal, Finance, Defense, and Manufacturing clients across 150+ languages with 3,500+ subject-matter linguists. For teams managing audit-sensitive content, contact us to discuss your security and compliance requirements directly.
FAQ
What is an SSCP under MDR Article 32?
The summary of safety and clinical performance is a public document required by MDR Article 32 for implantable and class III devices. It states the device's intended purpose, its residual risks, and a summary of the clinical evidence. A notified body validates it and it's published through EUDAMED.
Does the SSCP need a patient version and a professional version?
Yes. MDR Article 32 and the MDCG 2019-9 guidance require the summary to be written for the intended user. When the device is used by patients, a separate lay-language version sits alongside the professional one. Both carry the same facts in different registers.
Which languages does an SSCP have to be translated into?
The languages accepted by every member state where the device is placed on the market. That can reach all 24 EU official languages for a wide launch. Each language version has to match the validated source and the EUDAMED entry.
Who validates the SSCP?
The notified body reviews and validates the SSCP as part of conformity assessment before it goes to EUDAMED. Translation has to preserve the validated content exactly, which is why a documented ISO 17100 revision step matters. Changes after validation follow the update route in MDCG 2019-9.
How does the SSCP connect to EUDAMED?
The validated SSCP is uploaded to EUDAMED, where it becomes publicly accessible. Under Decision (EU) 2025/2371 the four EUDAMED modules are mandatory from 28 May 2026, so the summary's terminology has to stay consistent with the UDI and device data already registered. Existing devices must be registered by 28 November 2026.
Does ISO 13485 or ISO 17100 matter more for SSCP translation?
You need both. ISO 13485 makes the translation supplier part of your device quality system with traceable records. ISO 17100 sets translator qualification and the independent second-linguist check. For an SSCP that a notified body validates, neither one covers the other's job.
