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Quality and Regulatory are not final checkpoints — it’s embedded into every stage of the product lifecycle. Our QA & RA support services ensure your product performs reliably, meets regulatory standards, and maintains consistency from early feasibility through scalable production.
Design Controls
Design Controls
We deploy tried and tested design controls practices into our product development process to ensure you establish a sturdy foundation within your device's design history file. Establishing this way of working early on builds momentum and confidence at each stage of development.
Regulatory Strategy & Compliance
Regulatory Strategy & Compliance
As you know (or will quickly find out) navigating compliance is one of the biggest challenges in product development. At Five Design and Development, we integrate regulatory strategy into every stage of the process—reducing risk, avoiding costly delays, and ensuring your product meets the highest safety and quality standards. When developing medical devices, we align designs with FDA, IEC, ISO, and CE/UL standards, embedding compliance requirements into your product from day one.
Risk Management + Verification & Validation
Risk Management + Verification & Validation
Our process and people identify risks early and apply mitigations, so we can validate safety with confidence through structured verification and validation activities. We verify and validate designs through simulation, benchtop testing, and field trials, confirming performance against design requirements and specifications.
Structured Product Development
Structured Product Development
Navigate the complex product development process with confidence using our systematic approach which encompasses design controls, risk management, and regulatory compliance, ensuring your product meets all necessary standards while maintaining development efficiency.
Documentation & Submission Readiness
Documentation & Submission Readiness
We prepare DHF, DMR, and traceability matrices to support smooth audits and faster approval cycles. Our people have done this before with great success, so you can trust our work product will get you through the next phase of development.
Accelerated Manufacturing Ramp-Up & Product Cut-in
Accelerated Manufacturing Ramp-Up & Product Cut-in
Transition seamlessly from development to production. Our manufacturing expertise helps optimize your design to fit your desired production processes, reducing your time to market, and ensuring consistent product quality from day one.
Certification Support
Certification Support
From EMC and safety testing to international certifications, we manage third-party processes and resolve technical issues efficiently.
Manufacturing Process Troubleshooting & Development
Manufacturing Process Troubleshooting & Development
Resolve production challenges quickly and effectively. We identify root causes, implement sustainable solutions, and develop robust manufacturing processes that support scalable production and quality requirements.
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