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.
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.
- 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.