A portfolio of targeted training and development courses, delivered over one day and those marked with  delivered as half-day awareness workshops:-

  • CE Marking of Medical Devices: Key considerations and steps to compliance.
  • Clinical Evaluation: Requirements of MED DEV 2.7/1 Rev 4 & Medical Device Regulation.

  • Corrective & Preventive Action (CAPA).

  • EC In Vitro Diagnostic Device Regulation (IVDR): Requirements.

  • EC Medical Device Regulation (MDR): Requirements.
  • Internal Auditing.

  • ISO 13485:2016: Quality management systems — Requirements for regulatory purposes.

  • ISO 14971:2012: Application of risk management to medical devices.

  • Medical Device Directive to Medical Device Regulation: Changes & Transition Planning.

  • MDSAP: Preparing for Medical Device Single Audit Programme.

  • Post Market Surveillance Planning and Vigilance.

  • Preparing for an FDA Inspection.

  • Preparing for Notified Body Audit.

  • Technical Documentation & PMS Technical Documentation Requirements.
  • Usability.
  • UDI Unique Device Identification.

Each course is designed to be:-

  • Informative, practical, interactive and hands-on.

  • Represent up to date thinking on current and future requirements of the directives, common / technical specifications, standards and regulations.

  • Bespoke and wholly contextual to your business issues (in-house).

  • Contribute to continuing professional development.

Our courses are:-

  • Customised to your company’s requirements (in house only).

  • Delivered in-house (minimum 4 delegates) or off site.

  • Delivered by a QMS and/or Medical Device Regulation expert.

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