Turning innovation into safe, effective, market-ready medical devices takes more than inspiration – it takes experience, process and the right partner.
At Meridian Medical, we specialise in medical device product development – helping you navigate every stage of the journey from concept through design development, verification, validation and full-scale manufacturing. Whether you’re developing a new medical device or refining an existing one, our experienced team ensures quality, compliance, and efficiency at every step.
What We Offer
Design refinement & feasibility assessment When you share your concept or initial CAD drawings, we work closely with you to assess manufacturability, cost, materials, usability and risk. We identify potential problems early (e.g. Changes that could reduce Tooling cost, or improve its lifespan, raw material suggestions, or refinements to improve company cost), so you can avoid costly redesigns or product launch delays.
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Regulatory-ready verification & validation
We ensure your medical device product development process aligns with ISO 13485, and are happy to assist with CE marking, MDR, and FDA submissions, as well as any country-specific regulatory requirements. From product performance testing to packaging durability and safety, we validate and verify every design specification.
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Prototyping & pilot production
Whether you need proof-of-concept samples, usability prototypes, small batch or pilot builds, we have the tools and cleanroom facilities to deliver. These early versions help you test not just function but manufacturability, assembly, packaging and sterilisation readiness.
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Iterative design improvements
Based on feedback from testing, we iterate. We can help resolve design flaws, improve performance, manufacturability, assembly and cost efficiency. You benefit from our engineering know-how: materials expertise, tooling, precision cleanroom moulding, cleanroom assembly – creating an in-house seamless, scalable product development journey.
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Risk management & documentation
We can support you through the manufacturing risk assessment, Failure mode effect anaylsis, design history files, technical files and all required documentation, as well as being your base for regulatory submissions, and customer and supplier audits.
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Scalable transfer to manufacture
Once your design is validated, we prepare for full production, having ensured that tooling is correct, process validation is completed, and all the required quality systems are in place. Whether your needs are for limited runs or ongoing supply, we scale without compromising the quality or regulatory integrity of the product.
Why choose Meridian Medical? The Right Partner For You
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Experience that drives success
Since 1991, we’ve supported innovators and established companies alike. With over 30 years in medical device new product development, we’ve seen what works and what doesn’t – and how to avoid pitfalls that delay market entry.
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High-quality systems without multinational overhead
Get BSI ISO13485 certified systems, cleanroom production and regulatory compliance – but with the responsiveness, agility and lower cost compared to large multinationals. Less bureaucracy, faster decisions, more flexibility.
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Collaboration and transparency
We act as your partner, not just a vendor. We invest in understanding your goals, timelines, cost constraints, and risk profile. We communicate constantly, share test results, and engage you in decisions throughout.
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Risk reduction & faster time-to-market
By focusing on design validation and early risk mitigation, we help you avoid delays, failures and regulatory setbacks. The result: smoother development, better products, faster launch.
The Meridian Medical Device Product Development Process
Here’s what a typical medical device product development lifecycle with us looks like:
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Initial consultation & concept review
Share your idea, your goals, constraints (budget, timeline, regulatory). We work together to assess feasibility.
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Design & engineering
CAD development, material selection, risk analysis, manufacturability. Early prototypes and feedback cycles.
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Verification & validation
Performance testing, safety, durability, biocompatibility, regulatory compliance tests. Packaging, sterilisation, assembly trials as required.
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Pilot runs / small-batch production
Produce units in your target spec under cleanroom conditions, verify manufacturing consistency.
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Tooling & process validation
Finalise mould tooling, validate production process (efficiency, quality). Document and production transfer.
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Transfer to full-scale manufacturing
Ramp up to commercial supply, ensuring ongoing quality, traceability, and supply chain integrity.
Work With Us On Your Medical Device Product Development
Meridian Medical offers the capabilities, quality systems, and cleanroom manufacturing you’d expect from a global medical device leader – without the scale or cost of a multinational. We are here to help innovators, start-ups and established companies to bring products to market when in-house production isn’t practical or possible. With the right expertise, technology, and flexibility, we’re a trusted alternative to building it yourself or outsourcing overseas.
Let’s explore what we could build together. Contact us today to talk through your medical device development needs: timelines, validation scope, tooling, or just to get feedback on your current design.