Training & Mentoring
We offer a series of standard training packages which can be delivered at your site as competitive prices, or we can provide tailored training packages based on your specific company needs. As a role of an IVD consultancy, we can incorporate an expert overview of the regulations and standards, but we can also provide a perspective on your quality processes and strategy, this can not be provided by other notified body training courses.
Our standard training packages:
IP to IVD — IVD Regulation for Start-ups (1 day course)
A one day course aimed at start-up companies who need to gain an understanding on what an IVD is and what are the key implications of the IVD Regulation and quality management system is required as the company and products develop towards placement on market as an IVD Medical device. This training combines a series of training course material, Q&A sessions and workshops to allow a good understanding on what you need to know as a start-up IVD designer, importer or manufacturer.
IVD Design and Development (1 day course)
A one day course providing an introduction to the core elements of IVD design and development , this will include the main elements and phases of design and development from proof of concept to placement on market. This course is designed to help companies and the beginning of the IVD journey understanding the design inputs that are required, how to verify, validate and transition into device manufacturer ready for CE marking.
Overview of the EU IVD Regulation (1 day course)
A one day course providing a general overview of the IVD Regualtion including, risk –based classification, impact on the quality management system, techncial documentation and performance evaluation, Economic operator obligations, Packaging and labelling and post market activities.
The course incorporates a series of presentations, practical workshops, and Q&A sessions.
Introduction to the EU IVD Regualtion (2 day course)
A two day course providing a more in-depth understanding of the IVD Regulation exploring all the elements of the 1 day course but in greater detail. The course will take a closer look at vigilance, device classification, performance evaluation and transition planning from the IVD Directive to the IVD Regulation. This course will also focus on possible routes for transition of IVD devices currently on market to the IVD Regualtion.
Introduction to ISO13485:2016 Quality Management System (1 day course)
A one day course covering all aspects of how to establish, implement and maintain a quality management system compliant to the international standard ISO13485:2016. The course will provide practical guidance on document control, management responsibility, design and development, risk management, customer complaints, vigilance, CAPA and post-market surveillance.
The course will incorporate a series of presentations, practical workshops and Q&A sessions.
Introduction to ISO14971:2012 Risk Management (1 day course)
A one day course to provide a overview of the risk management standard ISO14971:2012. This will cover all elements of the standard including risk management planning, risk assessments, risk evaluation and risk control. It also provides pra-tical guidance on how to develop an overall risk-based approach to post market surveillance in line with the requirements of the IVD Directive and IVD Regulation.
For more information on any of the above courses, or to discuss any specific training requirements please contact us here.
Regulatory Workshop Session
In addition to the standard training packages we also offer additional add-on workshop sessions where we can be available for 1/2 day or 1 day sessions. We use current regulatory intelligence, as well as our previous industry experience and expertise to provide independent advice and guidance on your regulatory strategy, quality systems or transition plans. These sessions can be either one-off sessions, ad-hoc remote assessments or a more structured project. For further information please contact us here.
Introduction to the In-Vitro Diagnostic Regulation (IVDR)
IVDeology Ltd are proud to run the Management Forum course Introduction to the In-Vitro Diagnostic Regulation (IVDR).
This two day seminar will clarify the requirements applicable to in-vitro diagnostic devices under the IVD Regulation (EU) 2017/746. It will highlight the major changes to responsibility and product data expectations and will review the impact to industry.
For further information please click here.