Flexible Regulatory Affairs,
Every business’s regulatory journey is different. Whether you’re managing a short-term compliance project, filling a QA/RA capacity gap, or building a long-term partnership, IMed Consultancy provides scalable regulatory outsourcing and quality assurance consulting designed around your needs.
Our flexible engagement models give you instant access to experienced consultants who act as an extension of your team, helping you maintain compliance, meet deadlines, and accelerate your path to market.
Our Strategic Partnership Models
Our highly collaborative approach begins by defining your business objectives and scope. We provide three distinct ways to access our expertise, ranging from high-level strategy to the placement of skilled industry contractors.
Project-Based QA/RA Support
When you need focused, outcome-driven help, our consulting services provide the extra hands and specialist insight to deliver key milestones on time and on budget.
Typical projects include:
You’ll get a clear service fee, defined deliverables, and expert execution from consultants who’ve worked inside leading MedTech and diagnostics organisations.
Specialist Regulatory Affairs Support
Sometimes you need more than advice: you need a partner who can step in and deliver. IMed’s regulatory affairs support provides temporary, remote, or on-site professionals to lead projects, manage remediation work, or strengthen your in-house team.
Our consultants bring deep experience of MDR, IVDR, UKCA, and ISO 13485, and many more areas, offering the clarity and capacity to move your projects forward quickly and effectively.
Examples include:
- Outsourcing an entire compliance or remediation project
- Providing interim QA/RA managers or subject matter experts
- Supporting large-scale transitions or clinical PMS updates.
Retained Partnerships for Continuous Compliance
If your business needs ongoing guidance or recurring monthly tasks, our regulatory outsourcing model ensures continuous compliance without expanding your permanent team.
Retainers can cover everything from technical documentation reviews to ongoing project and program management, giving you predictable costs and consistent access to senior consultants. You’ll benefit from dedicated points of contact who understand your products and a proactive approach to regulatory updates.
Quality Assurance Consulting That Builds Resilience
IMed’s quality assurance consulting strengthens your systems and teams. Whether you need support maintaining your QMS, conducting internal auditing, or building continuous improvement plans, we offer hands-on expertise that integrates smoothly with your operations.
Our QA consultants can lead your quality design engineering efforts, manage CAPA processes, and train your internal teams in best practices for ongoing compliance.
Why Work with IMed Consultancy?
IMed Consultancy blends regulatory precision with practical flexibility. Our team has worked across the medical device, diagnostics, and digital health sectors, giving you confidence that your projects are in safe, experienced hands.
You’ll benefit from:
Frequently Asked Questions
Working with outsourced or embedded consultants can raise practical and strategic questions. Here are a few we often hear.
Regulatory outsourcing means partnering with external specialists to handle compliance projects, documentation, or QA/RA functions, saving time and reducing internal workload.
Yes. We specialise in placing industry experts for specific needs, including clinical PMS strategy, data collection, and report writing.
Outsourcing your project and program management ensures that complicated regulatory transitions are handled by professionals who understand the technical requirements and timelines, reducing the risk of project drift.
Absolutely. We provide experts who can integrate with your R&D team to ensure that quality design engineering principles are applied from the earliest stages of product development.
Let’s Build Your Regulatory Partnership
Whether you need regulatory outsourcing, quality assurance consulting, or long-term regulatory affairs support, IMed Consultancy delivers flexible, expert solutions tailored to your business goals.