Utilising Eurofins BioPharma product testing's full breadth of expertise

Why:

This case study addresses the challenges faced by a manufacturer of surgical devices.
In order to obtain FDA approval with a reduced number of available samples, the manufacturer approached Eurofins for assistance.
The aim was to provide the customer with the full range of services and expertise that Eurofins can offer to efficiently address and manage the challenge of bringing their medical device to market.

For Whom:

The case study is aimed at manufacturers of medical devices for surgical use.

How:

Experts from different Eurofins sites and departments were involved to develop a strategic approach to address the issues:

1. Developing a sterile packaging system: Eurofins Sterile Packaging is a service provider for the packaging, sterilisation and validation of medical devices. As developing customised solutions is our core business, we were able to effectively address the specific challenges and requirements of the customer.

2. Developing a testing strategy: With a reduced number of samples available for validation, Eurofins Consulting developed a rationale to reduce the number of batches required for testing, which was included in the shelf-life and transport simulation strategy document.

3. Collaboration between all three Eurofins Medical Device fields – Consulting, Testing and Packaging & Sterilisation services – with the aim of bringing the product to market in a short timeframe and with a limited number of samples available.

Outcomes:

The outcome was very positive, due to the successful approach. Access to a diverse team of Eurofins experts allowed the customer to tap into a wider range of specialised knowledge and experience, while reducing the number of suppliers.