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TOP MOST POPULAR COURSES AND COURSE SUITES OF WMDO
(At registration remember token ´FiHTA´)
Effective Monitoring of Medical Device Clinical Investigations
16 course suite
Product ID: 57
COURSE DESCRIPTION:
This comprehensive, self-paced 16 course suite provides you with all the necessary information, requirements and guidelines you need, including practical skills and tools to successfully accomplish medical device monitoring activities in compliance with Good Clinical Practices according to ISO 14155, 21 CFR part 812 and Japanese GCP for medical devices.
Through interactive multi-scenario case studies, glossary items, richly detailed charts, models and graphics, including audio and video presentations, you’ll uncover the fundamental processes, regulations, and techniques from the experts that will guide you throughout your career in medical device clinical investigations. Effective Monitoring of Medical Device Clinical Investigations was designed to get trainees up to speed and on the job quickly, efficiently and thoroughly.
PRICE:
Premium: €1441.- Basic: €1922.-
Risk Management for Medical Devices in EU and US
3 course suite
Product ID: 77
COURSE DESCRIPTION:
Learn to identify, implement, verify and maintain risk control measures to reduce risk associated with medical devices to an acceptable level.
Course 1: ISO 14971-2007 Review
Course 2: Preparing Risk Management File and which Techniques Apply
Course 3: Integrating Risk Management into your Quality Management System
PRICE:
Premium: €243.- Basic: €324.-
Clinical Evaluation for Market Approval and Clinical Trials
3 Course suite
Product ID: 125
COURSE DESCRIPTION:
Manufacturers planning to market their devices in Europe are now required to furnish clinical data in line with the new European Directives that came into effect as of March 21, 2010.
This intensely comprehensive 3 course suite on Clinical Evaluation for Market Approval and Clinical Trials will empower you with the essential information, requirements and guidelines you need to successfully and accurately conduct clinical evaluation under the new European Directives. From regulatory process and compliance to literature review and conformity; get on the right track to market approval today.
PRICE:
Premium: €462.- Basic: €616.-
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Introduction to Medical Devices from Idea to Market
11 course suite
Product ID: 158
COURSE DESCRIPTION:
This 11 course suite provides you with an overview of the major steps involved in bringing a medical device to the market starting from the initial idea all the way through to keeping a medical device safely on the market and ensure continuous improvement.
Courses are presented in a logical sequence thereby providing the learner with a clear overview of the different tasks involved while referring to more in depth courses available at WMDO on the different topics, but allowing the learner to get the full picture of the different elements involved in a minimum of time.
PRICE:
Premium: €1196.- Basic: €1595.-
Introduction to Digital Governance: A Four-Step Approach
Product ID: 184
COURSE DESCRIPTION:
In the medical device industry, control of your digital activities - including social media - is paramount to avoid fines and ensure that you have the proper strategies and structures in place to maximize commercial opportunities. This introductory course will outline a four-step approach that is easily implemented, yet robust enough to help companies address the rapidly evolving Value+Risk equation that must drive online marketing and communication activities.
Introduction to Digital Governance is designed for anyone considering the use of online tools such as social media to inform target audiences about their company, increase internal or external engagement, or promote their products, while maintaining proper control of these activities. This could include people in Compliance, Legal, Marketing, Product Development/Management, Communications, Regulatory Affairs, Quality Assurance, Human Resources, and Training and Development.
PRICE:
Premium: €212.- Basic: €282.-
ISO 14155: In Depth Review
7 course suite
Product ID: 68
COURSE DESCRIPTION:
The ISO 14155 standard provides crucial guidance and support to any party involved in a clinical investigation -primarily to Sponsors (including monitors) and investigators, but also ethics committees, regulatory authorities and notified bodies implicated in the conformity assessment of medical devices.
The latest 2011 revision brings significant changes and improvements throughout the majority of areas on clinical research with medical devices covered within the document. This course provides not only a description of the contents of the document but a comprehensive and practical guidance on how to implement the requirements - including many examples.
WMDO clinical expert and TC 194 WG4 convener for the ISO 14155, Danielle Giroud has compiled for you this revealingly in depth and up to date review covering everything from the scope of the newly revised ISO 14155 and ethics considerations, to clinical investigation planning, conduct and close out, as well as Sponsor and Investigator responsibilities.
“ISO 14155: In Depth Review” consists of 7 distinct courses and jam-packed with over 3.5 hours of valuable, state-of-the-art information for professionals who can’t afford not to be current.
PRICE:
Premium: €357.- Basic: €775.-
