Medical Device & Diagnostics Regulatory Services
Expert support from product classification, documentation to approval, and post-market compliance.
Comprehensive Regulatory Support
From early planning and submissions to audit readiness and post-market obligations
Support built for device companies navigating complex quality and regulatory demands.
We help teams align product strategy, documentation, quality systems, submissions, and post-market responsibilities so they can move with greater confidence across key regulatory markets.
Quality Assurance & Compliance
- ISO 13485 QMS Implementation
- Risk Management per ISO 14971
- Gap Analysis & DHF Remediation
- Post-Market Quality Support
- Verification & Validation
- Manufacturing Process Development
- Supplier & Internal Audits
- SOPs & Documentation
Regulatory Affairs
- Regulatory Strategy & Planning
- Global Regulatory Assessment
- Device Classification (EU MDR)
- 510(k), PMA & De Novo Submissions
- Predicate Device Selection
- Pre-Submission Meetings (FDA)
- Technical File Creation (MDR/IVDR)
- GSPR Compliance
- MDD to MDR Transition
- Labelling, IFU & UDI
- Notified Body Liaison
- CDSCO Registration Support
Clinical Evaluation Report (CER)
- Clinical Evaluation Plan (CEP)
- Literature Search & Review
- Clinical Background Analysis
- State of the Art Assessment
- PMS Data Integration
- Risk Management Integration
- Benefit-Risk Analysis
- Notified Body Approval Support
Performance Evaluation Report (PER)
- Performance Evaluation Plan (PEP)
- Scientific Validity Report (SVR)
- Analytical Performance Report (APR)
- Clinical Performance Report (CPR)
- Tech File Submission & Review
- IVDR Readiness Audits
- Gap Assessment in PER
- Mock Audits
Post-Market Surveillance
- Complaint Handling & Investigation
- Adverse Event Reporting
- Field Safety Corrective Actions
- CAPA Implementation
- PMS Protocols & Reports
- Post-Market Performance Follow-up
- Post-Market Clinical Follow-up
- Trend Analysis & Reporting
Regulatory Pathways
Practical guidance for major device approval pathways across key markets
US FDA
- 510(k) Pre-Market Notification
- De Novo Classification
- Pre-Market Approval (PMA)
- Quality Management System Regulation (QMSR)
- Drug Establishment Registration
- Registration and Listing of Medical Devices
CE Marking
- MDR 2017/745 Compliance
- IVDR 2017/746 Compliance
- Technical Documentation
- Design History File
- Notified Body Assessment
- UDI Database Registration
CDSCO Registration
- Medical Device Registration
- Import License
- Test License
- Manufacturing License
- Free Sale Certificate (FSC)
Key Deliverables
Documentation packages designed to support approvals, audits, and lifecycle compliance
Design History File (DHF)
Technical Documentation
Risk Management File
Clinical Evaluation Plan & Report
Biocompatibility Assessment
Labeling & IFU
QMS Documentation
Submission Dossiers
Usability Engineering File
Summary of Safety & Clinical Performance (SSCP)
General Safety & Performance Requirements (GSPR)
Performance Evaluation Plan & Report
Scientific Validity Plan & Report
Start Your Device Approval Journey
Discuss your device, target market, and compliance roadmap with our team
Schedule Free ConsultationMedical Device & Diagnostics FAQs
These questions cover the most common topics companies ask before starting a medical device or diagnostics regulatory project.
Does Yuhitech support medical devices as well as in vitro diagnostics?
Yes. The service scope covers both medical devices and diagnostics, allowing support for companies with products that fall into either category or operate across both segments.
Can Yuhitech help with India, EU, and US regulatory pathways for devices?
Yes. Support is aligned to India and EU priorities while also covering US-facing regulatory needs, helping businesses plan submissions and documentation for multiple regulated markets.
What type of documentation support is included?
Typical support can include technical documentation, submission support materials, gap assessments, quality-related documentation, compliance planning, and readiness work for regulated market requirements.
Is the service only for new market entry projects?
No. The work can also support remediation, compliance strengthening, post-market needs, documentation improvement, and ongoing regulatory alignment for existing products.
Can smaller device companies use this service effectively?
Yes. Smaller and growing device companies often benefit from structured regulatory guidance because it helps them prioritize documentation, submissions, and compliance actions without building a large internal team immediately.
Can Yuhitech support devices at different risk classes?
Yes. Support can be adapted to different device contexts, classifications, and documentation demands depending on the regulatory pathway and target market.
Does the service include quality system support such as ISO 13485?
Yes. Quality system support is an important part of the medical device offering where compliance readiness depends on stronger process and documentation alignment.
Can Yuhitech help with technical file or design history documentation?
Yes. The service can support technical documentation, design-related records, and other structured materials needed for review, submission, and audit readiness.
Is post-market surveillance part of the medical device service?
Yes. Post-market obligations, ongoing compliance, and related lifecycle activities can be included where they are relevant to the client product and market scope.
Can Yuhitech work with internal device engineering or quality teams?
Yes. The medical device service often works best in coordination with client engineering, quality, or leadership teams so documentation and compliance efforts stay aligned.
What kind of businesses benefit most from this service?
Manufacturers, diagnostics developers, innovators, and growing device companies benefit when they need practical support across submissions, documentation, quality, and regulatory planning.