Medical Device Reprocessing Instructions Development
Clear, evidence-based reprocessing instructions are a cornerstone of compliance for reusable medical devices — and a critical factor in ensuring device safety, performance, and longevity. We help manufacturers develop and validate cleaning, disinfection, and sterilisation instructions that are both regulatory-compliant and practical for real-world use.
Whether you’re developing a new product or updating documentation for an existing device, our team brings the scientific expertise, regulatory insight, and in-house laboratory capability to deliver reprocessing instructions that stand up to scrutiny.
Our laboratory is built for reusable device testing. We have access to a wide range of disinfection and sterilisation technologies in-house. This allows us to simulate real healthcare environments, test your device across multiple workflows, and generate robust, repeatable data.
Regulatory Requirements for Reprocessing Instructions
Under EU MDR, FDA regulations, and applicable international standards, reusable medical devices must be supplied with validated Instructions for Use (IFUs) that cover the full reprocessing cycle. This includes:
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Manual or automated cleaning
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High-level disinfection
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Sterilisation cycles (e.g., steam, low temperature, hydrogen peroxide)
Poorly defined or unvalidated reprocessing instructions not only create regulatory risk — they also compromise patient safety and device longevity. Authorities now expect comprehensive, evidence-backed IFUs, and increasingly reject vague or template-based claims.
We provide an end-to-end service for the development, testing, and validation of medical device reprocessing instructions, including:
We support manufacturers at every stage of the product lifecycle, including:
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Early-stage development teams looking to establish feasible cleaning and sterilisation approaches
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Established device companies seeking to validate or improve their existing reprocessing IFUs
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Regulatory teams preparing submissions or responding to notified body or FDA queries
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Designers and engineers evaluating new concepts or redesigning legacy products
From benchtop prototypes to market-ready devices, we tailor our service to meet your exact needs.
We won’t keep you waiting
We respond to all enquiries within minutes of receiving them.
Our lead times match the urgency and demand in the market – we offer industry-leading turnaround times because we know how critical reliable data is for your project. While what you’ve seen is our typical lead time, the final timeline will depend on your specific study requirements. But rest assured, we’ll do everything we can to deliver even faster.
Think of it like a relay race – we’ll hand over the data baton as quickly as possible, so you can keep moving forward on your medical device journey.
