Setting the standard with our expert Microbiology team

As a manufacturer of a sterile medical device, meeting the necessary ISO 13485, regional and global regulations can be a challenging and complex process. It is critical to work with a notified body that understands the industry and has the experience to review and confirm your product’s readiness for market – efficiently, promptly and robustly.

From the experts

The implementation of the appropriate sterilization technique can be the difference between a medical device not receiving certification and one which is approved for use on the market to enhance and save patients’ lives. Contact us early in the planning process for your sterile medical device submissions and certifications.

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