Medical Device Consultancy & EU MDR Compliance Support
Expert Quality Management, Regulatory Strategy & Project Lifecycle Services for Medical Device Manufacturers
Medical device manufacturers operate in one of the most highly regulated environments in the world. IQC provides specialist medical device consultancy services to support organisations at every stage of the product lifecycle — from early regulatory strategy through to market access, compliance maintenance, and continuous improvement.
Working collaboratively with SechMed, IQC delivers an integrated approach that combines regulatory and quality expertise with structured project lifecycle management, ensuring medical device projects remain compliant, efficient, and commercially viable.
MDR 2026 and 2027 deadlines approaching fast - Are you ready?
Why Choose IQC for Medical Device Consultancy?
IQC has extensive experience supporting medical device manufacturers across Ireland, the EU, and international markets. Our consultancy services are designed to reduce regulatory risk, accelerate time to market, and strengthen long-term compliance.
Our expertise includes:
Medical Device Quality Management System (QMS) development and optimisation
ISO 13485 implementation, maintenance, and audit readiness
EU MDR and IVDR regulatory strategy and compliance support
Regulatory documentation and technical file support
Internal audits, supplier audits, and remediation programmes
E-QMS selection and implementation guidance
We work closely with senior regulatory, quality, and operations teams within SME and multinational organisations, providing practical, implementation-focused support aligned to business objectives.
IQC & SechMed Partnership
To provide end-to-end medical device support, IQC collaborates with SechMed, a specialist provider of medical device project and lifecycle management services.
This collaboration allows clients to access:
IQC’s regulatory, quality, and compliance expertise
SechMed’s structured project management and lifecycle execution capability
Together, we support medical device programmes across design and development, regulatory submission preparation, verification and validation planning, and post-market compliance activities. All engagement and governance remain coordinated through IQC, ensuring continuity, accountability, and a single point of contact.
Transitional Regulations removes the ‘sell off provision’ for both the MDR and IVDR. This means that devices already placed on the market can continue to be made available or put into service until the revised expiry of the certificate or until the shelf life of the device.
We recommend you read the Regulation to understand how it may affect your organisation.
Quality Management System (QMS) Consulting
Our consultants help organisations:
Establish compliant and scalable QMS frameworks
Prepare for certification and surveillance audits
Address nonconformities and regulatory findings
Integrate risk management and design controls
Our approach ensures QMS processes are effective, auditable, and proportionate to organisational size and device classification.
Project Lifecycle Management
Through our collaboration with SechMed, IQC supports medical device projects throughout the full lifecycle, including:
Regulatory planning during design and development
Verification and validation strategy support
Cross-functional project coordination
Regulatory submission readiness
This integrated approach ensures regulatory, quality, and project management activities remain aligned and controlled.
Regulatory Strategy & Compliance Support
IQC provides structured regulatory strategy support to help organisations:
Interpret and apply MDR / IVDR requirements
Develop compliant technical documentation
Prepare for notified body engagement
Support legacy device transition and remediation
Our consultants work pragmatically with internal teams to align regulatory compliance with commercial timelines and product portfolios.
Market Access & Registrations (EU & USA)
IQC supports manufacturers preparing for market access in the EU and other regulated markets. Services include:
Regulatory submission planning and review
Technical documentation gap analysis
Post-market surveillance and vigilance system support
Change management and regulatory impact assessments
Our focus is on sustainable compliance that supports ongoing market access and future product development.
Upcoming regulatory change: FDA QMSR (21 CFR Part 820)
Learn how the transition to a QMSR aligned with ISO 13485:2016 will impact your quality system from February 2026.
We can help with:
Start Up - Design And Development – QMS Development - Regulatory Strategy – Regulatory Filings and Registrations (EU/USA etc) Business Planning - Finding Distributors - Market Access – Supplier and Internal Quality Auditing – Training - QMS Software (pre and post market options available).
Testimonials
I enjoyed the training. Small number of participants allowed everyone to be active. Great trainer.
Agata O'Reilly
I feel that I acquired a good and broad understanding of the subject and developed my skills to a high degree. Very excellent standard of training delivered by the course trainer.
Gerard Wallace - Creganna Medical
Philips experience and knowledge was excellent. Discussions were excellent.
John Younan