Medical Devices optimized for Probe Disinfection

IIb class medical devices / UV-C / MDR 2017/745 / FDA / AOAC

We recently had the privilege of assisting one of our clients, a global medical company dedicated to disinfection process, allowing a new, faster, and more robust disinfection process in their IIb class medical devices.

The technology behind the device is straightforward : a UV-C based technology that allows the disinfection of ultrasound probes. It has developed a system which replaces chemistry with photons and thus constitutes a technological breakthrough.

With its technology based on UV-C radiation, the manufactured medical devices are radically different systems that use state-of-the-art technology to meet all disinfection standards. This would help develop hospital hygiene systems and simplify the lives of healthcare professionals in terms of safety, time and responsibility.

Context of our client

The client operates in many countries and manufactures and distributes medical devices. They approached us for a new medical device manufacturing process that would fully address some of their key challenges:

• Be compliant with the updated standards of Medical Device Regulation (EU) 2017/745
• Be compliant with the UK and US standards
• Challenge the sterilant and the disinfectant faculties of the device

Our approach

The approach we took was very specific. As a microbiologist specialist, our consultant accompanied the company to face the challenges.

First, the methodology used for the sterilant, potency and simulated tests have been redesigned to meet the standards.
Then, a follow-up was done on the conducted tests. We faced the scientific challenges and were able to answer AOAC and FDA expectations.
We also took part in the constitution of the De Novo file to manufacture beyond Europe, to make sales in the USA.

Nevertheless, it involved all departments and resources, which made it very complex

• Management of a microbiological study with a Medical Device
• Design and drafting of microbiological study protocols with partner laboratories
• Support for specific microbiology questions from the authorities
• Writing & Proofreading reports of study results as part of a regulatory technical file (Microbiology, optics, etc.)
• Coordination of studies between partner laboratories on the project
• Animation of relations with study partners (Laboratory Managers, AOAC & FDA organization) in the context of scientific expertise

We helped coordinate multiple departments and resources to implement a new manufacturing process for our client’s medical devices.

Our approach involved a comprehensive and cross-functional effort that spanned R&D, industrialization, quality assurance and regulatory affairs.

Results

In conclusion, the validation of medical devices is a complex and highly regulated process, and our commitment to providing an appropriate support to our clients is founded on our extensive knowledge and experience within the industry.

With our expert guidance, we seek to alleviate the challenges associated with medical device validation and empower our clients to deliver safe and effective products to the market.