Microbiology and Sterile Medical Devices

Microbiological Testing Medical Devices BSISterile product certification can be a complex and challenging process for medical device manufacturers who need to achieve the necessary standards, outlined under ISO 13485:2016.

As a Notified Body, we have a team of qualified and experienced industry microbiologists that can help you navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing.

What is Microbiology and Sterile Medical Devices

To support your achievement of the necessary standards – outlined under ISO 13485:2016 – and to keep patients safe, BSI offers a team of qualified and experienced industry microbiologists allowing you to navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing.

ISO 13485 is supported by standards covering specific requirements, including:

  • The use of appropriate controlled manufacturing processes that establish a consistent product bio-burden prior to the sterilization process (e.g., use of clean rooms and/or controlled environments)
  • Validation and control of the primary packaging process to assure the integrity of the sterile pack
  • The validation and control of the sterilization process

Compliance with issues like those outlined above is dependent on effective quality system assessments. We carry out quality system assessments to ensure compliance with the standards of ISO 13485, as well as other global regulations  (e.g. Medical Devices Directives, CMDCAS, Japanese PMD Act, and sterilization standards). We also perform technical documentation reviews and conduct assessments and reviews of disinfectants under the Medical Devices Directive.

Why choose BSI for your sterile product certification?

We have a unique approach to sterile product certification – that sterilization and microbiology is a specialized process and therefore requires a specific set of skills. Risk is the key. We believe the risk to the patient is too great not to use specialists in microbiology. All our microbiology assessments are carried out by fully qualified Microbiologists.

Our microbiology team currently encompasses over 10 technical experts, with over 110 years experience between them with a global reach, with auditors throughout Europe, USA and Asia.

  • Benefit from over 110 years of microbiological experience
  • Independent experts to verify the output of your internal experts and subcontractors
  • State of the art knowledge of current and emerging best practice and avoidance of issues that could be catastrophic
  • Peace of mind knowing that the you have been successfully reviewed by leading experts who have implemented and audited thousands of effective sterilization processes
  • Confidence that your process has been thoroughly reviewed by the experts who participate in the work that defines the standards
  • We believe that our approach to microbiology and sterilization adds value to certification and helps to ensure our customers are successful and patients are protected


BSI is trusted by the two largest global sterilization service providers to complete their Quality and Sterilization Audits, and is the Notified Body of choice for over 90% of contract sterilization registrations worldwide.

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