Regulatory Compliance

Avicenna Surgical are compliant with all industry standard accreditations

In order to meet the compliance obligations of our stakeholders, Avicenna Surgical will comply with all regulatory requirements
applicable to the UK and our organisation as illustrated on the non-exhaustive list:

ISO 13485 2016

ISO 13485:2016

ISO 13485 2016

ISO 9001:2015

ISO 14001 logo

ISO 14001:2015

GDPR

General Data Protection Regulations (GDPR)

ISO 14001 logo

UKCA marking requirements

  • UK Medical Device Regulation 2002 (as amended)
  • Medical Device Directive 93/42/EEC
  • UK Health & safety law
  • Financial and tax law
  • Labour Standards requirements including the Modern Slavery Act
  • Employment law
  • All applicable aspects of UK environmental law
  • Avicenna Surgical policies, values and procedures

Our regulatory team perpetually review changes in legislation to ensure Avicenna Surgical fulfills all applicable legal obligations
on an ongoing basis.