FDA translation 510(k) · PMA · Labeling · Q-sub

English submission packs and CN↔EN IFU work for US market—substantial equivalence, labeling and REMS-related materials.

서비스 범위 보기 견적 받기
99%+
Medical review coverage
24h
Quote response
NDA
Confidentiality
Multi
Market filings

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
Medical device translation

FDA translation services

Registration dossiers, IFU/labeling, clinical documents and QMS files—full lifecycle medtech language support aligned to MDR/FDA/NMPA requirements.

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Regulatory dossiers

Structured translation of CE/FDA/NMPA dossiers, CER, clinical evaluation and DoC per authority templates and review checklists.

Regulatory templates Glossary Medical review Version control
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IFU & labeling

IFU, labeling, packaging and warnings with figure-alignment QC—text matched to symbols and artwork.

Warning alignment Figure match Multi-market Rush lane
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Clinical & CRO docs

Clinical protocols, ICF, CRO reports and investigator brochures—medical linguists plus second medical review.

GCP context Blinded workflow Bilingual review TM management
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✅

QMS & audit files

Quality manuals, procedures, audit records and supplier files—for multilingual QMS maintenance.

ISO 13485 MDR/FDA Traceability Secure handling
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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.

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Non-active devices

IVD reagents and instruments—instructions, performance evaluation and registration with analytic metric accuracy.

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IVD

Standalone and embedded SaMD—UI, help and cybersecurity copy balancing regulation and UX.

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SaMD

High-risk orthopedics and cardiovascular—clinical and risk files with optional SME sampling.

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CRO & sponsors

Aesthetic and consumer devices—compliance copy and marketing with regulatory tone.

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Distributors

Hospital procurement and bid specs—formal technical and compliance translation.

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Typical 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
Medtech compliance scenarios

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
Medtech translation QA

Typical deliverables & formats

Depending on scope, we can deliver:

IFU & labeling copy Registration dossiers Clinical & CRO documents QMS & audit files Risk management reports Glossary & review log

Project workflow

From compliance confirmation through filing support—with QA gates and PM oversight.

  1. 01

    Compliance & purpose

    Confirm use case, target authorities, languages and PHI handling.

  2. 02

    Medical terminology

    Assign medically qualified linguists and project glossaries.

  3. 03

    Translation & medical QA

    Dual review with optional SME sampling on critical sections.

  4. 04

    Filing-ready delivery

    Handover for submission or release with glossary reuse.

의료기기 번역 과제와 해결책

규제 경로가 복잡—오역은 반려나 안전 리스크로 이어집니다.

규제 차이

MDR/FDA/NMPA 요건 상이

당사 접근법:

대상 시장 템플릿과 검수 체크리스트

의학 용어

임상·공학 용어의 정확성 필수

당사 접근법:

의학 배경 번역가 + 제2 의학 검수

라벨·경고

IFU·라벨은 도면과 일치해야 함

당사 접근법:

도문 정렬 QC 및 DTP

기밀·감사

출시 전 데이터 민감

당사 접근법:

NDA, 권한 분리, 감사 추적

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

English German French

FDA 510(k) IFU translation

CN IFU to FDA-format English IFU and labeling.

Outcomes

Faster response to FDA supplement requests

Languages

Chinese English

어가 의료기기 번역을 선택하는 이유

의학·규제 양면 전문성으로 반려·안전 리스크 감소.

의학 번역가

의료기기 배경 번역·교정

규제 경로

MDR/FDA/NMPA 문서 구조

IFU 전문

경고문·서식 엄격 정렬

기밀 준수

의료기기 데이터 처리 기준

의료기기 번역

관련 리소스

관련 서비스, 업종별 솔루션, 고객 사례를 확인하세요.

관련 서비스

관련 업종 솔루션

고객 사례

FAQ

자주 묻는 질문

견적, 납기, 기밀 유지, 파일 형식에 대한 일반적인 질문입니다.

FDA Translation Services 분야 번역가 요건은?
업종 경험 번역가·교정, 용어집, 컴플라이언스 체크, 필요 시 SME 검수.
규제·표준 문서 경험?
FDA/MDR, IEC, ISO 등 업종별 IFU, SOP, 계약, 매뉴얼 대응.
장기 콘텐츠 유지 방법?
TM·용어집, 변경분 번역, 전담 PM, 릴리스 주기 동기화.
FDA Translation Services 비용은 어떻게 산정되나요?
분량, 언어쌍, 전문 분야, 납기, 형식을 기준으로 견적합니다. 샘플 또는 파일을 보내주시면 24시간 내 회신합니다.
가격에 영향을 주는 요소는?
언어쌍, 콘텐츠 유형, DTP, 공증, 용어집, 긴급 여부, 장기 프로젝트 물량 등이 주요 요인입니다.
납기는 보통 얼마나 걸리나요?
일반 문서는 하루 2,000–3,000 단어 기준으로 계획하며, 웹/소프트웨어는 모듈별 단계 납품이 가능합니다.

전문 번역 지원이 필요하신가요?

Send a sample, target markets and release plan—we respond within 24 hours with a fda translation assessment and proposal.

견적 받기 문의하기