Deda MedCheck
(Global Medical Device Search)
Uphold Compliance, Walk With You Every Step
Your Dedicated Steward for Medical Device Startups, Powering Your Confident Growth
Book Regulatory Expert Consultation
SERVICE ITEMS
Service Items
Annual Consulting
  • Domestic & Overseas Regulatory Consultation & Interpretation
  • On-site Coaching
  • Mock Audit
  • Domestic & Overseas Regulatory Training
  • Corporate Compliance Consultancy
  • Global Market Access Route Planning for Products
  • Process Validation Optimization Advice
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Preparations
  • Pre-registration Preparation
  • R&D & Verification
  • Registration Application Planning
  • Plant & Workshop
  • GMP System
  • Pilot Production
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Inspection & Evaluation
  • Registration Testing
  • Biological Evaluation
  • Animal Testing
  • Clinical Evaluation
  • Clinical Trials
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Application & Review
  • Dossier Preparation
  • Pre-acceptance Consultation
  • Acceptance
  • Supplementary Request & Expert Meeting
  • GMP System Inspection
  • Registration Approval
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Licensing & Amendments
  • Manufacturing License Application
  • Business License Application
  • Registration Modification
  • Registration Renewal
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Post-market Management
  • Instructions Revision
  • Other Post-market Matters
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Annual Consulting
  • Domestic & Overseas Regulatory Consultation & Interpretation
  • On-site Coaching
  • Mock Audit
  • Domestic & Overseas Regulatory Training
  • Corporate Compliance Consultancy
  • Global Market Access Route Planning for Products
  • Process Validation Optimization Advice
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United States
  • Medical Device Registration Classification
  • Q-Sub/Pre-Sub Pre-Submission Consultation
  • Medical Device 510(k) Premarket Notification
  • Enterprise Registration & Product Listing
  • PMA Premarket Approval (For High-Risk Class III Devices)
  • Quality System Compliance
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European Union
  • Market Access Strategy
  • Technical Documentation & Clinical Services
  • Quality & Risk Management Systems
  • Software & Digital Health Compliance
  • Packaging & Labeling Compliance
  • Audit & Inspection Preparation
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Other Countries
  • Japan
  • Southeast Asia
  • Middle East
  • Australia
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Trusted by Global Medical Device Enterprises

Focus on medical device technology, offer professional consulting for technical transformation.

德大合作客户-BGI Genomics
BGI Genomics
德大合作客户-Sihuan Pharmaceutical
Sihuan Pharmaceutical
德大合作客户-HeartCare Medical
HeartCare Medical
德大合作客户-Yuwell
Yuwell
德大合作客户-Ximo
Ximo
德大合作客户-Fujifilm
Fujifilm
德大合作客户-Puliyan
Puliyan
德大合作客户-KaVo Group
KaVo Group
德大合作客户-Visionary AI
Visionary AI
德大合作客户-Airdoc
Airdoc
德大合作客户-Yidu Zhengkang
Yidu Zhengkang
德大合作客户-Maiyuan Biotechnology
Maiyuan Biotechnology
德大合作客户-Zecheng Medical
Zecheng Medical
德大合作客户-Yundi Medical
Yundi Medical
SERVICE OUTCOMES
Service Achievements

We strictly comply with laws and regulations to maximize clients' benefits. We provide hands-on, affordable support for medical device innovators to fuel industry growth and entrepreneurs' success for mutual gains—this is our core philosophy for the Industry Steward service.

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ABOUT US
About Us

Focus on Medical Device Technology

Offer Professional Consulting for Technical Transformation

Founded in 2014, Deda focuses on pre-market regulatory and technical consulting for medical devices. Core businesses cover product registration, clinical trials, equivalent device evaluation, overseas registration, import registration, QMS establishment & maintenance, technology transfer, medical-industrial commercialization and proof-of-concept verification.

China's medical device industry is booming alongside maturing regulations. Jiangsu ranks among China's top medical device provinces, with Suzhou as its pivotal industrial city. Rapid sector expansion has driven strong demand for specialized consulting. Rooted in this market landscape, Suzhou Deda Enterprise Management Consulting Co., Ltd. was established by industry experts with 10 to 20 years of professional experience.

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company profile

PROFESSIONAL FIELD
Professional Fields
  • Medical Devices

    Medical device compliance consulting to accelerate registration approval.

  • In Vitro Diagnostics
    IVD regulatory guidance for global market access.
  • Software-based Medical Devices
    Regulatory support for medical device software development and certification.
  • AI & Digital Health

    Compliance planning for AI & digital health products for safe market launch.

KNOWLEDGE CENTER
Knowledge Center
Free Consultation