Here are some of the most common questions we are asked about the DCB 0129 and DCB 0160 Standards:

Our Free Members Area answers many more questions including:

  • What is the Medical Device Directive?
  • What’s involved in becoming compliant with the standards?
  • How long does it take to comply with the Standard?
  • What documents need to be written?
  • Who signs off the documents?
  • Is there a certificate?
  • If an app is only for lifestyle and wellness purposes, does DCB 0129 apply?