Empowering the regulatory affairs professional

High Edge Consulting launches six new training courses in 2013

Regulatory specialist and training expert to the medical device industry, High Edge Consulting, has launched six new training courses for 2013. The move sees High Edge Consulting expand its portfolio to offer 16 public training courses to the medical device industry, covering regulatory affairs, quality management, sterilisation and contamination control issues and standards.

‘We are seeing a clear trend in increased investment in training across the industry,’ said Peter Rose, Managing Director at High Edge Consulting. ‘Last year alone, more than 200 people attended a High Edge training course, with a significant rise in delegates from across continental Europe.

‘Moreover, training is no longer seen as just a box ticking exercise for learning and development targets, perhaps reflecting how regulatory compliance is moving up the corporate agenda as a priority business activity. Regulation is no longer something that medical device businesses simply “put up with” but rather an important investment area that protects both patients and the company brand.’

The six new training courses cover innovative and growth areas for the medical device industry, as well as key standards and important areas of activity that Regulatory Affairs and Quality Assurance team member would be involved in. They are:

  • The Medical Device Directive Recast – What does it mean for you?
  • Apps and Software as Medical Devices
  • Clinical Evaluations: how to comply with MEDDEV 2.7/1
  • Clinical Trials for Medical Devices – the Best Approach
  • Post Market Surveillance & Vigilance
  • Process Validation – The regulatory requirements for IQ, OQ, PQ.

Rose continues: ‘Regulatory affairs professionals need to leave a training course feeling confident that they can apply their new found knowledge. They want to be able to do the job themselves. This is certainly our goal with High Edge training courses. We aim to provide innovative courses that reflect the day-to-day needs of the compliance team.’

2013 Training Courses and dates
CE marking – An introduction to the Medical Devices DirectiveCEMD0112&13/310&11/9
Compilation of a Technical File/Design DossierTECH0113/619/11
Risk Management 1 – ISO 14971RISK0126&27/325&26/9
Risk Management 2 - Usability Engineering &
Electrical Medical Equipment
RISK0216/517/10
Biological Evaluation of Medical Devices - ISO 10993-1BIOL0117&18/042&3/10
ISO 13485 Internal AuditorINT0A018&9/56&7/11
Sterilization – Ethylene Oxide AdvancedSETO0125/613/11
Sterilization – Gamma & Electron Beam AdvancedSGAM0130/415/10
Cleanroom Good Manufacturing Practice (GMP)CGMP0111/73/12
FDA Quality System Inspection technique (QSIT)QSIT012/512/11
Apps and Medical Device SoftwareAPPS0119/627/11
Post Market Surveillance and VigillancePMS0123/58/10
Clinical 1 – Clinical Evaluations – How to comply with MEDDEV 2.7/1CLIN0124/430/10
Clinical 2 – Clinical Trials for Medical Devices – the
best approach
CLIN025/610/12
The Medical Device Directive Recast – What does it mean for you?RECAST17/9
Process Validation – The regulatory requirements for IQ, OQ, PQPROC013/712/12

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