Training
Looking for a training course specific to your requirements?
Do you want more personal training rather than with 40 other delegates?
Do you want your trainers to come to you?
The UK office of Emergo Group (formerly Mediqol) routinely provides in-house training on a variety of regulatory and quality assurance topics, covering requirements in all the major markets around the world. Typically, our training courses comprise:
- a presentation by an Emergo Group consultant;
- an interactive question and answer session after the presentation;
- where appropriate, a practical workshop session covering specific examples and cases from our files.
All attendees of the training will be provided with a printed copy of the presentation and an Emergo Group certificate of training for their records. Typically, training is conducted at the customer’s site, although it can be conducted at our Sheffield offices if preferred. Up to 20 individuals may attend each training session.
Training can be provided on a wide range of topics including the following popular areas:
Regulatory Requirements: preparation and submission of 510(k)s in USA; Far East requirements, including India, China, Japan.
Clinical Study Management: an overview of clinical investigation requirements in EU; protocol and investigator’s brochure preparation; procedures for ethics committee approval and MHRA notification.
Medical Device Reporting: an overview from a practical perspective, including what is/isn’t reportable; how field actions work; the specific reporting requirements of, for instance, Japan.
Post-Market Surveillance: how to address post-market surveillance requirements from a practical perspective; what PMS activity triggers to look for and what would be regarded as a trigger by a Notified Body.
Quality Systems: requirements of the US Quality System Regulation; key differences between QSR and ISO 13485: 2003; the FDA QSR audit process using QSIT.
Introduction to the IVD Directive: IVD device classification; conformity assessment options; data requirements; quality system requirements; specific requirements for self-testing IVD devices; requirements for IVD devices intended for performance evaluation.
