Microbiology and Sterile Medical Devices

Microbiology and Sterile Medical Devices

Red Overlay
Microbiology and Sterile Medical Devices
Microbiology and Sterile Medical Devices
Red Overlay

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.

Microbiology Assessment Planning Guide

Microbiology assessment planning guide

We have developed this guide to provide information on what to expect during a BSI microbiology audit and to support you in preparing for your audit.

Download the planning guide

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.

Resources to support you

Why choose BSI for your product compliance to the MDR?

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme. Our Microbiology team has a broad range of medical, pharmaceutical, industry and regulatory experience, including product design and development, manufacturing, sterilization, and product testing.

Our technical specialists have an average of 20 years’ experience in the industry and understand the scientific aspects of the sterilization process. This world-leading experience supports you as a manufacturer by providing expert feedback on controlled environments and the sterility of your medical device.

BSI is trusted by the two largest global sterilization service providers to complete their QMS and sterilization audits. We are the Notified Body of choice for over 90% of contract sterilization registrations worldwide.

Request a quote

A notified body’s perspective on the clinical evaluation requirements under the Medical Device Regulation

jmdr articleUnderstanding of the clinical evaluation process for medical devices against the requirements of the MDR, relevant Medical Device Coordination Group guidance documents is critical for all manufacturers.

Hear from BSI’s Richard Holborow, Head of Clinical Compliance in his recent article in the Journal of Medical Device Regulation on the requirements for clinical evaluation under the MDR from a Notified Body’s perspective and how to meet those requirements.

Download the article

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.

Stay up to date with the latest updates from BSI