Medical Device Consulting

Your Trusted
Consulting Partner

UNIQ MedTech delivers end-to-end regulatory, quality, and engineering support for companies navigating MDR, FDA, and CDSCO compliance. Drive faster approvals with a partner who understands the entire lifecycle.

Free Consultation Our Services
150+ Happy Clients
12 Fortune 500
50+ Published Papers
500+ Devices Approved
Who We Are

A Trusted Regulatory & Engineering Partner

UNIQ MedTech brings together experienced medtech professionals, regulatory specialists, and design engineers to provide end-to-end compliance support. Our disciplined approach combines global standards expertise with practical execution for faster approval and safer products.

Comprehensive Regulatory Strategy

From MDR and FDA to CDSCO pathways, we map the quickest route to market with tailored risk-based plans.

Quality and Risk Management

Integrated QMS, clinical evaluation, and CAPA execution to meet audit readiness for ISO 13485 and ISO 14971.

Engineering & Documentation

Design controls, verification/validation, and technical files prepared with format compliance for faster review.

MedTech Compliance
100%
Compliance-Focused Approach
Who We Are

Your End-to-End
MedTech Solutions Partner

UNIQ MedTech Solutions brings deep multidisciplinary expertise to every engagement — combining regulatory knowledge, quality systems experience, and mechanical engineering precision under one roof.

Global regulatory expertise spanning MDR, FDA, and CDSCO frameworks
ISO 13485-aligned quality management system design and implementation
Precision mechanical engineering from concept through design validation
Single-partner accountability for your entire device development journey
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QMS Setup for Medical Devices
Package 1

QMS Setup

Establish a robust Quality Management System tailored for medical devices. Our comprehensive QMS setup ensures compliance with ISO 13485 standards, enabling efficient quality control, documentation, and continuous improvement processes.

What We Offer:

QMS implementation for medical devices
ISO 13485 QMS Setup
QMS Documentation Development
Quality Manual Preparation
Standard Operating Procedures (SOP) Development
CAPA (Corrective and Preventive Action) System Implementation
Complaint Handling System
Post Market Surveillance (PMS) compliance
Change Control Management
Document Control Systems
Quality Training Programs
Internal Audit Setup
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Package 2

Gap Analysis

Identify and bridge gaps in your current systems against international standards. Our expert gap analysis services provide detailed assessments and actionable recommendations to achieve full compliance with regulatory requirements.

What We Offer:

ISO 13485 Gap Analysis
EU MDR Gap Assessment
FDA Compliance Gap Analysis
QMS Gap Assessment
Documentation Gap Review
Audit Readiness Assessment
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Gap Analysis for Regulatory Compliance
Regulatory Documentation Services
Package 3

Regulatory + Documentation

Navigate complex regulatory landscapes with our expert documentation services. We prepare all necessary technical files and regulatory submissions to ensure your medical devices meet US and EU requirements for market approval.

What We Offer:

Technical File preparation
Design History File (DHF) preparation
Device Master Record (DMR) preparation
Device History Record (DHR) documentation
Regulatory Strategy (US + EU)
CE Marking Support
US FDA 510(k) support
Risk Management per ISO 14971
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Package 4

Audit & Compliance Support

Prepare for and excel in regulatory audits with our comprehensive audit support services. From internal audits to FDA inspections, we ensure your systems are audit-ready and help implement corrective actions for sustained compliance.

What We Offer:

Internal Quality Audits
Change Control Management
Regulatory Audit Preparation (FDA / ISO / Notified Body)
Mock Audits
Post-audit CAPA support
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Audit and Compliance Support
0+
Happy Clients
0
Fortune 500 Companies
0+
Research Papers
0+
Medical Devices Audited
Get In Touch

Let's Discuss
Your Project

Our team is available now — while our website is being upgraded, our expert consultants are ready to deliver professional, tailored regulatory and engineering support immediately.

Our Location
UNIQ MedTech Solutions
Pune, Maharashtra
India - 412105
Email Us
sales@uniqmedtech.com
WhatsApp
+91 90228 29410
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