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:
- Defined and validated reprocessing instructions (cleaning, disinfection, sterilisation)
- Supporting testing data and documentation for every claim
- 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
Frequently Asked Questions
How many reprocessing cycles should we validate?
It depends on what you claim in the IFU and the intended service life of the device. Regulators expect validated, device‑specific instructions that reflect real‑world use and reprocessing across the claimed lifetime; this stems from ISO 17664‑1/‑2 and the FDA’s Reprocessing Guidance. In practice, you justify the number of cycles based on risk, device design, and intended re‑use then generate evidence that your device tolerates those cycles without loss of safety or performance.
Do you actually run hundreds of cycles, or can we extrapolate from fewer?
Both approaches are acceptable with a documented, risk based justification.
Can we have the devices back at the end for functionality testing?
Yes. We can return conditioned test articles so your team can perform post reprocessing functional, mechanical, and performance testing.
How do you pick a “worst‑case” or master product for life‑cycle testing?
We run a worst case justification to select a master product (or SKU) that is most challenging to reprocess and to endure repeated reprocessing.
How do disinfection/sterilisation targets fit into life‑cycle testing (A₀, SAL, etc.)?
Automated thermal disinfection (washer disinfectors): we verify the A₀ value (time–temperature lethality), e.g., A₀ = 600 or A₀=3000 depending on policy/clinical need, using ISO 15883 concepts and your stated parameters. Steam sterilisation (moist heat): we validate cycles to achieve SAL ≤10⁻⁶, using recognised cycle development/monitoring methods.
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.
