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.
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.