Guidance notes

The free guidance documents below are available for immediate download. 

• What is ISO 13485:2003? - This guidance document explains in simple, easy to understand terms, the fundamental points of ISO 13485:2003.
• Practical Guide to Understanding ISO 13485:2003 - BSI has developed this guidance document in order for you to have a basic knowledge of the details within the ISO 13485:2003 standard.
• Medical Device Guidance (MEDDEV's) - Official guidance documents produced by the European Commission
• Medical Device Notified Body Recommendations (NB-Med's) - Recommendations on the Directives from the European Notified Bodies Medical Devices Group 
• Consensus Statements - Agreed interpretations from the European Notified Bodies Medical Devices Group
• Other Helpful Documents - A collection of other documents that are of interest to medical devices manufacturers

For more information about these guidance documents, please Contact Us.