Medtech translation: language on the regulatory path
Medtech export faces complex regulatory paths—translation errors risk rejection, delayed market access or patient harm. Linguist covers IFU, labeling, registration dossiers and clinical documents with market-specific QA gates.
We maintain project glossaries and confidentiality controls, figure-alignment QC and DTP fidelity, with terminology reuse across product families.
- MDR/FDA/NMPA template delivery
- Medical linguists + second medical review
- IFU/label figure-alignment QC
- NDA and role-based confidentiality
IFU translation services
Registration dossiers, IFU/labeling, clinical documents and QMS files—full lifecycle medtech language support aligned to MDR/FDA/NMPA requirements.
Regulatory dossiers
Structured translation of CE/FDA/NMPA dossiers, CER, clinical evaluation and DoC per authority templates and review checklists.
IFU & labeling
IFU, labeling, packaging and warnings with figure-alignment QC—text matched to symbols and artwork.
Clinical & CRO docs
Clinical protocols, ICF, CRO reports and investigator brochures—medical linguists plus second medical review.
QMS & audit files
Quality manuals, procedures, audit records and supplier files—for multilingual QMS maintenance.
Product types
Active/passive devices, IVD and SaMD—with medical and regulatory linguist matching.
Active devices
Active implantable and non-implantable devices—IFU, labels and registration with electrical/biocompatibility terms.
Read the full solution briefNon-active devices
IVD reagents and instruments—instructions, performance evaluation and registration with analytic metric accuracy.
Read the full solution briefIVD
Standalone and embedded SaMD—UI, help and cybersecurity copy balancing regulation and UX.
Read the full solution briefSaMD
High-risk orthopedics and cardiovascular—clinical and risk files with optional SME sampling.
Read the full solution briefCRO & sponsors
Aesthetic and consumer devices—compliance copy and marketing with regulatory tone.
Read the full solution briefDistributors
Hospital procurement and bid specs—formal technical and compliance translation.
Read the full solution briefTypical compliance scenarios
Initial filings, change notifications, clinical supplements, overseas distribution and post-market surveillance all generate multilingual documentation. We confirm purpose, authorities and formats at kickoff.
- CE/FDA/NMPA registration
- IFU and label updates
- Clinical trials and CRO collaboration
- QMS audits and supplier files
Medical quality assurance
Medical-background translation with second medical review—focused checks on dose, indications, warnings and device descriptions. Labels and IFUs follow dedicated figure-alignment workflows.
- Medical glossary and abbreviations
- Dual check on dose and indications
- Dedicated warning review
- Filing-ready archives and reuse
Typical deliverables & formats
Depending on scope, we can deliver:
Project workflow
From compliance confirmation through filing support—with QA gates and PM oversight.
- 01
Compliance & purpose
Confirm use case, target authorities, languages and PHI handling.
- 02
Medical terminology
Assign medically qualified linguists and project glossaries.
- 03
Translation & medical QA
Dual review with optional SME sampling on critical sections.
- 04
Filing-ready delivery
Handover for submission or release with glossary reuse.
医療機器翻訳の課題と解決策
規制経路が複雑—誤訳は却下や安全リスクにつながります。
規制の差異
MDR/FDA/NMPA で要求が異なる
当社のアプローチ：
対象市場のテンプレートとチェックリスト
医学用語
臨床・工学用語の正確性が必須
当社のアプローチ：
医学背景の翻訳者＋第二医学レビュー
ラベルと警告
IFU・ラベルは図と厳密に一致
当社のアプローチ：
図文整合QCとDTP
機密と監査
未上市製品データは機微
当社のアプローチ：
NDA、権限管理、監査ログ
Reference projects
Reference medtech and IVD project scenarios.
Class II EU MDR submission pack
IFU and technical file EN/DE/FR for notified body review.
Outcomes
Passed notified body written inquiries
Languages
FDA 510(k) IFU translation
CN IFU to FDA-format English IFU and labeling.
Outcomes
Faster response to FDA supplement requests
Languages
語家の医療機器翻訳が選ばれる理由
医学と規制の両面から、却下・安全リスクを低減。
医学翻訳者
医療機器背景の翻訳・校正
規制パス
MDR/FDA/NMPA 文書構造
IFU 専門
警告文と版式の厳密整合
機密コンプライアンス
医療機器データ取扱基準
関連リソース
関連サービス、業界ソリューション、事例をご覧ください。
関連業界ソリューション
- Medical device translation
Medtech registration, IFU, labeling and clinical docs—medical linguists plus review for MDR/FDA/NMPA compliance.
- MDR translation
EU MDR 2017/745 technical files, clinical evaluation, PMCF and DoC—aligned with notified body review language.
- FDA translation
FDA 510(k), PMA, Q-sub and labeling/IFU translation aligned with US FDA formats and terminology.
FAQ
よくある質問
見積もり、納期、機密保持、ファイル形式に関する一般的な質問です。