Medical Device Reprocessing Validation
Reusable medical devices are expected to endure repeated cleaning, disinfection, and sterilisation cycles without compromising safety or performance. As regulatory expectations tighten, manufacturers can no longer rely on generic or unsupported reprocessing claims. That’s where our Medical Device Reprocessing Validation service comes in.
Under EU MDR and global regulatory frameworks, manufacturers must prove that their devices can withstand the full range of reprocessing cycles recommended in their Instructions for Use (IFU) — for the entire duration of the product’s claimed lifetime. Unverified claims of “10-year lifespan” without supporting data are no longer accepted.
Regulatory bodies are pushing back, requiring:
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Defined and validated reprocessing instructions (cleaning, disinfection, sterilisation)
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Supporting testing data and documentation for every claim
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Testing that reflects real-world use and reprocessing frequencies
This applies across all device classifications — from Class I reusable surgical instruments to electronic systems, endoscopes, hospital beds, and patient monitoring equipment.
Our Approach to Reprocessing Validation
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.
