Regulatory and Quality Solutions
Tailored to Your Product

IMed Consultancy delivers flexible, expert-led regulatory and quality support to help MedTec and IVD innovators bring safe, effective products to market. Our services cover everything from Regulatory Affairs Consulting to Representation, ensuring compliance, confidence, and control throughout your product lifecycle.

Two professionally dressed colleagues, a man and a woman, smiling and collaborating while looking at a laptop screen in a bright office setting.

Regulatory Affairs Consulting

We help you manage complex regulations with confidence. IMed’s Regulatory Affairs Consulting team helps you plan, prepare, and manage submissions across MDR, IVDR, FDA, and international frameworks. We ensure your documentation, strategy, and approvals stay on track.

Product Development and Validation

From early design through to verification and validation, IMed helps you align innovation with compliance. Our Product Development and Validation experts support risk management, technical documentation, and testing to ensure your product meets every standard before launch.

A close-up of a person's hands typing on a laptop at a white desk, with a colleague in the background pointing at a computer monitor displaying financial charts and graphs.

QMS and eQMS Solutions

Build quality into everything you do. IMed designs and implements QMS and eQMS systems that comply with ISO 13485, ISO 9001, and FDA 21 CFR 820. We’ll help you achieve audit readiness, streamline operations, and use your QMS as a strategic asset for continuous improvement.

Clinical Writing

Clear, compliant, and regulator-ready documentation. IMed’s Clinical Writing services cover Clinical Evaluation Reports (CERs) and Performance Evaluation Reports (PERs), delivering clear, compliant, and regulator-ready documentation that accelerates market review.

A close-up of a person's hands interacting with a tablet, which projects a sophisticated digital interface featuring various floating data visualizations, including bar graphs, line charts, scatter plots, and a pie chart in a dark setting.

UK Responsible Person (UKRP)

Secure your position in the Great Britain market with trusted UKRP services from IMed. We act as your legal bridge to the MHRA, handling device registrations, maintaining technical documentation, and managing all ongoing communication with UK regulators to ensure your business remains fully compliant with UK MDR requirements

European Authorised Representative (EUAR)

For manufacturers outside the EU, IMed provides expert EUAR representation through IMed EUAR Ltd. We act as your official independent representative within the European Union, managing your compliance under MDR and IVDR, fulfilling your EUDAMED obligations, and providing a professional point of contact for all National Competent Authorities.

A close-up of a person's hands typing on a laptop at a white desk, with a colleague in the background pointing at a computer monitor displaying financial charts and graphs.

Partnering and Talent Solutions

Expand your team with experienced QA/RA professionals. IMed’s Partnering and Talent Solutions provide flexible, on-demand access to skilled consultants who integrate into your organisation, short-term or long-term.

Training

Empower your team with targeted, practical Training sessions from IMed Consultancy. From MDR/IVDR updates to QMS implementation and post-market surveillance, our workshops build in-house confidence and compliance capability.

Ready to Simplify Compliance?

Whether you’re building your first product or managing global portfolios, IMed Consultancy delivers the clarity, strategy, and support to help you achieve lasting compliance success.