Medical Devices

Method Validation

Our validation department regularly performs identification and routine method validation work as well as engaging in a wide range of bespoke R&D projects, such as claims support regarding antimicrobial efficacy, proof of concept, and challenge testing.

We perform the following routine testing:
•   Biological indicator enumeration
•   Preservative efficacy
•   Microbial identification
•   Process validation
•   Cleaning validations (medical devices)
•   Determination of bioburden method recovery efficiency

We can offer expedited turnaround times for the above Validation testing services. Expedited testing can significantly increase the speed in which you get your results and help you meet tight deadlines. Like what you see? Feel free to get in touch with us today to discuss more!

Additionally, the validation department performs validation and method suitability testing of the methods utilised in our Quality Control testing procedures as well as quality checks of all the media prepared in house.

Log reduction testing

One of the regular types of projects the validation department is involved in are those designed to assess the antimicrobial effectiveness of wound dressings as compared to a market leader (predicate device). In these projects, novel dressings were compared using a log reduction test where an inoculation was made to a number of dressings and then tested over a defined period to monitor the log reduction over time.

Our validation department has extensive experience with testing on silver ion technology in wound dressings. Additionally, we have provided data to support claims of antimicrobial activity on coated devices, photo-activated plastics and biofilm reduction products.