Customised Training at Your Premises & Distant Learning Modules

Why is Training a necessary investment: "Staff Training & Competence in FDA & CE Mark Compliance is a regulatory requirement" - a lack of training of your staff will rank as non-compliance!

At Your Premises / Sites -Courses available

Distant Learning Modules - 

FDA CFR 21 Regulations, QSR, Y2K & Latest Requirements

  • 1 Full Day QSR  - For all Line Managers & Supervisors
  • 2 Full Days QSR, DMR, DHF, 510(k), PMA, Submissions - For Regulatory & Quality Managers

Being Updated

Understanding the Medical Devices Directive (93/42/EEC)

  • 1/2 Day General Introduction - For All Staff
  •  1 Full Day Standard Course - For Line Managers & Supervisors 
  • 2 Full Days - Comprehensive - For Regulatory & Quality Managers

Being Updated

CE Auditing Compliance

  • 1 or 2 Full Days - For your nominated Audit Staff
  • Training Your Staff On Your Premises Practical Auditing
  • Regulatory Compliance - No more Notified Body Non-compliances at your Surveillance Audits

Being Updated

Practical Hands-on guidance working with Staff,
your Quality Management System, your SOP's & WI's,
Technical Documentation, your Processes, your Devices
Achieving Full Regulatory Compliance