Microbiologie et Dispositifs Médicaux Stériles

Microbiologie et Dispositifs Médicaux Stériles

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Microbiology and Sterile Medical Devices
Microbiology and Sterile Medical Devices
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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 is 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 readiness for market.

Notified Body - BSI The Netherlands (2797) - reviews medical devices to ensure their conformity to the European Regulations.

Approved Body - BSI UK (0086) - conducts conformity assessments under the UKCA Scheme.

BSI Group America Inc. is a recognized Auditing Organization.

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.


Lou Stinson, Global Head of Microbiology, BSI

Meet our experts

Sterilization of medical devices is a specialized process and requires specific knowledge and expertise. With an average of over 20 years of combined microbiology experience, we are the Certification Body of choice for over 90% of contract sterilization sites worldwide.

Our microbiology technical specialists fully understand the scientific aspects of the sterilization process and through their world-leading experience can provide expert assessment of controlled environments and medical devices sterility in all areas including dental, ophthalmic, orthopedic, vascular, active implantable, active, devices utilizing medicinal substances, devices utilizing animal tissue and general sterile devices.


Microbiology and Sterile Medical Devices