Your Compliance Partner!
Trusted partner empowering medical device innovators by simplifying the complexities of regulation, guiding ideas from concept to market with precision, integrity, and excellence to deliver life-changing, compliant solutions.
Our Services
Market Access
We support clients in navigating through complex regulatory requirements needed to successfully bring healthcare products to market. We help clients develop strategies for successful product launch.
Our market access services include:
- Market access strategy and planning
- Market entry and pathway assessment
- Regulatory and reimbursement strategy
- Stakeholder engagement and market launch planning
We take a strategic, evidence-based, and market-focused approach to market access. By understanding, we help clients anticipate challenges, make informed decisions, and accelerate the path from regulatory strategy to market access.
AdProm Review
We support medical device and IVD manufacturers in reviewing advertising and promotional materials to ensure claims and communications are accurate, substantiated, and aligned with applicable regulatory requirements.
Our services include:
- Review of advertising and promotional claims
- Assessment of regulatory and compliance requirements
- Review of product claims and intended use statements
- Evaluation of scientific and clinical substantiation
- Review of labelling, brochures, websites, and digital content
- Regulatory review of marketing and sales materials
We help ensure promotional communications are clear, accurate, and compliant, while effectively communicating product benefits and supporting responsible market positioning.
Technical Assistance
We support MDs and IVD manufacturers in preparing, reviewing, and maintaining comprehensive technical documentation to meet applicable regulatory requirements and support market access.
Our services include:
- Technical documentation and technical file preparation
- EU MDR and IVDR regulatory documentation support
- Clinical evaluation
- Post market surveillance, regulatory gap assessments and remediation
- Technical documentation review, updates, and maintenance.
We help ensure your technical documentation is accurate, complete, consistent, and aligned with applicable regulatory requirements throughout the product lifecycle.
RA Training & Capacity Building
We provide tailored regulatory affairs training and capacity-building programmes to strengthen internal regulatory expertise and support compliance for medical devices and IVDs.
Our services include:
- Regulatory affairs and compliance workshops
- Technical documentation and regulatory submission training
- Clinical and performance evaluation training
- Post-market surveillance and vigilance training
- Regulatory strategy and market access training
- Bespoke training programmes for regulatory and cross-functional teams
We help organisations build practical regulatory capabilities, strengthen internal expertise, and maintain compliance throughout the medical device and IVD product lifecycle.
European Representative
We provide European Authorised Representative services for MDs and IVD manufacturers based outside the EU, supporting compliance with applicable requirements under the MDR and IVDR.
Our services include:
- European Authorised representation
- Regulatory compliance support
- In country registration support
- Technical documentation and DoC oversight
- Support during inspections
- Vigilance, incident reporting, and post-market surveillance support
We act as your trusted regulatory partner in the EU, helping ensure continuous compliance and supporting the successful market access of your medical devices and IVDs.
Muhammad Sughis, PhD – Founder & Managing Partner
With PhD in Biomedical Sciences and over 20 years of experience across academia, biomedical research, and regulatory affairs, I have supported the development and regulatory compliance of medical devices and in vitro diagnostics. My expertise spans regulatory strategy, technical documentation, clinical evaluation, market access, and regulatory compliance throughout the product lifecycle.
About Us
We are a regulatory affairs consulting firm dedicated to helping Medical Device and IVD companies navigate complex regulatory requirements and successfully access global markets.
Our team provides practical, tailored regulatory support across the product lifecycle—from regulatory strategy and technical documentation to market access, European Authorised Representative services, advertising and promotional material review, and regulatory training and capacity building.
We work closely with manufacturers, start-ups, and established organisations to provide clear, reliable, and commercially focused regulatory solutions. Our goal is to simplify regulatory complexity, strengthen compliance, and help our clients bring safe, effective, and compliant products to market with confidence.
For queries, please use the contact form or write directly to:
info@cuemans.com