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Microbiology and Sterile Medical Devices

Placing your sterile medical device on the market.

As a sterile medical device manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed to the market

It's critical to work with an EU Notified Body, UK Approved Body or Auditing Organization that understands the industry and has the experience to review and confirm your product’s market readiness.

Bringing compliant products efficiently and safely to the market might be a challenging process for medical devices manufacturers. We offer standard and dedicated product review services providing you with efficient pathways to bring your device to market.

What is a sterile medical device?

A sterile medical device is a device that must be free from viable bacteria or other microorganisms and their spores. Sterile medical device requirements are defined by national or regional standards and regulations, which detail the level of sterility assurance. Sterilization of a medical device may include exposure to ethylene oxide, gamma irradiation, steam, dry heat, or chemical sterilization under defined conditions, and any necessary post-treatment required for the removal of by-products.

Microbiology audit and assessment

Microbiology audit is essential to reduce patient risk and is an integral part of sterile medical devices assessment. These include:

  • Verification of effective controls for pre-sterilization bioburden and microbiological cleanliness.

  • Assessment of environmental monitoring and controlled environment.

  • Verification of effective implementation of sterility assurance levels through sterilization.

  • Assessment of suitability and effectiveness of disinfectants and sterilizers.

  • Assessment of suitability and effectiveness of instructions for end user cleaning, and disinfection.

  • Assessment of product endotoxin testing including source.

Our Experts

Meet our experts

Sterilization of medical devices is a specialized process and requires specific knowledge and expertise.

  • Lou Stinson, Global Head of Microbiology, BSI

    "We are a truly international team with a deep knowledge of device sterilization processes."

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Whether you're starting the certification process, looking to transfer or just need to discuss options for your business, we can help.

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