Quality &
Regulatory Services

Quality & Regulatory Services


At FiunEx, we specialize in guiding medical device and IVD manufacturers to achieve compliance and market access. Our strength lies in our extensive experience and impactful interactions with key regulatory bodies, including the U.S. FDA, Japan's PMDA, Europe's Notified Bodies, China's NMPA, and other international authorities. Many of our team members have previously held positions within these organizations, providing valuable insights for strategic planning.

Our services cover the entire product development spectrum, from inception to post-market support. Whether you need assistance with Notified Body selection, Pre-IDE preparation, or Advisory Panel Meetings, our experienced consultants will craft and execute global regulatory strategies to expedite your commercialization efforts.

FiunEx's approach to medical device quality consulting allows you to maintain control over your projects while accessing external support. Whether you want to enhance in-house capabilities or require specialized expertise, our team is here to help you succeed. Navigating medical device regulations can be challenging, but we're here to streamline your regulatory approval process and ensure compliance with post-market requirements worldwide. Choose FiunEx as your partner, and let's unlock the full potential of your medical devices.



Regulatory Affairs

Regulatory Dossier Remediation

Global Regulatory Expertise: USFDA, IVDR, MDR, Health Canada, CDSCO, ANVISA, UKCA, NMPA and Others

Software as a Medical Device

Non-Conformance Management

Ensuring Compliance to Regulations

Verification and Validation

Agile, Digital and tandard Validation Approaches

Process & Transport Validation

Method & Cleaning Validation

CSV, Enterprise Resource Planning (Coordination and Support)

Product Validation

Continuous Rolling Product Validation

Validation as a Service

Quality Management

Ensuring Organizational, Production and Service Consistency

Non-Conformance Management: Deviations and CAPAs

Quality Management System Remediation

Complaint Management, Post Market Surveillance etc.

Risk Management

Risk Management ISO 14971, ICH 9

Risk Management Remediation

Safety Assurance Case

Reliability Analysis

Failure Analysis

Correct application of Risk Management Methodologies

Risk Analysis

Hazard Analysis

Ensuring Safe Compliant Products

Supply Compliance

Trade Compliance support

Good Distribution Practice GDP

Transport Validation

Track & Trace Solutions

Cold Chain Compliance

Ensuring End-to-End Supply Chain Compliance


Agile, Digital and Standard Qualification Approaches

Line, Equipment & Instrument Qualification

Clean Room Qualification

Technology Transfer

Facilities and Machinary Qualification

Laboratory & Quality Control

Laboratory & Quality Control

Ensuring Compliance in Laboratory Environment

LIMS / ELN Controlled Implementation & Support

Lean optimization and Six Sigma

Technical Writing Support

Product Verification

Design Transfer

Laboratory to Manufacturing Scale-up

EHS and Biosafety

Digital Compliance

Ensuring Digital Solution Compliance

GDPR and Data Privacy

EIFU Electronic Instructions for Use

Record Management & Digital Signatures

IT Security ISO 27001

Compliance Project Management

Ensuring accurate delivery of services in first go

R•QMS: ISO 9001, ISO 13485 (Implementation management, Audits etc.)

Project Quality Management

Leading Programs to Project and Beyond

Due diligence, Mergers & Acquisitions

Manufacturing Compliance

Ensuring Production Environment Compliance

Quality Engineering

Optimized Product Quality

Industry 4.0 / Manufacturing 4.0

Manufacturing Execution Systems

Process Automation

Validation of Distributed Control Systems


Validation as a Service

case studies

case studies