The following courses on understanding, implementation and auditing are planned:
Understanding and Implementation courses
- Establishing compliance with the Medical Device Directive 93/42/EEC (MDD)
This course represents the most comprehensive solution to compliance with the Medical Device Directive. Regulatory and standards principles are examined, the issues surrounding implementation discussed and the benefits of new management processes evaluated.
- FDA Quality System Regulation
This course will enable you to obtain the most up-to-date information available on the Quality System Regulation and how compliance with the regulation is determined through the use of the Quality Systems Inspection Technique (QSIT.)
- Introduction to ISO 13485
This one day introductory course will give students a broad understanding of the ISO 13485 Quality Management Systems requirements, including the proposed revisions. In addition, the concepts of ISO 14971 - The Medical Device Risk Management Standard - will be introduced. This course is highly interactive with lively debate and in-class discussion, real life examples, and exercises.
- Introduction to the Medical Device Directive 93/42/EEC (MDD)
This one-day introduction to the MDD covers the background to the Directive and its key features.
- Medical Device Design (and Development) Control
This course will enable you to obtain the most up-to-date information in relation to design and development control requirements as defined in the FDA Quality System regulation and BS EN ISO 13485:2003.
- Medical Device Risk Management - ISO 14971:2007
This course provides a thorough introduction and interpretation of ISO 14971: risk management, throughout the product lifecycle.
- Process Validation
This course is designed to ensure delegates fully understand the essential business of and regulatory requirements for process validation. The programme is enhanced by the use of two case studies.
- Risk Management: ISO 14971
Covering the application of Risk Management to Medical Devices, ISO 14791:2005. Assessment of Risk using FMEA, FTA or Hazop techniques.
Auditing courses
