Market compliance

Extensive experience in:

Training, documentation, systems development and remediation

  • Quality Management Systems and Compliance with ISO 13485:2016
  • Risk Management for Medical Devices - EN ISO 14971-2012 (including Annex Z's)
  • Software Development Lifecycle Processes - IEC 62304:2006 +A1:2015

European Directives:

Training, documentation, systems development, remediation, representation with Notified Bodies and Competent Authorities, Applications and Non-conformities.

  • Medical Devices Directive 93/42/EC
  • Medical Devices Regulation 2017/745/EU
  • IVD Directive 98/79/EC
  • IVD Regulation 2017/745/EU
  • Radio Equipment Directive - 2014/53/EU
  • General Data Protection Regulation - 2016/679/EU and national implementations in member states (privacy policies, application, data privacy impact assessment) 
  • Environmental Regulations - including reporting and registration requirements for individual member states
  • Waste Electrical and Electronic Equipment Directive - 2012/19/EU
  • Battery and Battery Accumulator Directive - 2006/66/EU
  • Packaging Directive - 94/62/EC

US FDA Regulations:

  • 21 CFR 820 Training
  • DHF Remediation
  • 510(k) Applications