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MEDICAL DEVICE TRANING COURSES
SOLUTIONS
The collection of content that aims to prioritize and analyze processes such as subject, department, person, and time, based on determining the information needs of businesses, is intended to ensure productivity.
MEDICAL DEVICE REGULATION (MDR)
TRAINING
Implementation of the Medical Device Regulation (MDR) for CE marking
This training course aims to offer guidance on implementation of the requirements stipulated in the Medical Devices Regulation (MDR). It focusses on enabling you to draw up a clear concept or project plan, and how to integrate the requirements into your business and your documentation.
Moreover, you should gain confidence and expertise to evaluate and implement more specific requirements on your own. The MDR is the legislation detailing the requirements that manufacturers have to meet to place medical devices on the market in the European Union. The MDR focusses on device safety and performance, emphasizing pre-market requirements, conformity assessment, quality management aspects, post-market surveillance (PMS), transparency and traceability.
The Regulation will affect all medical device manufacturers, importers, distributors and EU Representatives. Subcontractors/suppliers will also be affected, as will manufacturers of some devices without a medical purpose (for example, devices used for esthetical body modification, or contact lenses to change eye colour without correcting vision).
CE MARKING
TRAINING
Medical Devices CE marking
The medical devices CE marking course is designed to provide participants with the knowledge to assist their companies in getting products to market quickly. You will gain knowledge of the requirements of the Medical Device Directive and the CE marking approach. Participants will be able to provide leadership for their organizations when placing medical devices on the market in the European Union.
Application of the In Vitro Diagnostics Directive
Application of the In Vitro Diagnostics Directive course has been designed to enable you to explore the IVD Directive, gain a greater understanding of the requirements and thus enable your IVD devices to be placed on the European market efficiently. You will be able to apply the requirements of the directive to create technical documentation to support the product throughout its lifecycle.
ISO 13485
TRAINING
ISO 13485:2016 Clause by Clause
Implementing ISO 13485 course has been designed to provide you with the knowledge and process steps to enable them to effectively implement a Quality Management System in line with the requirements for ISO 13485 certification. The course introduces the concepts needed to understand, develop, and implement a quality management system.
Demonstrate your ability to provide medical devices and related services that meet quality and regulatory demands in line with ISO 13485:2016 Medical Device requirements for a Quality Management System (QMS). This course enables a clause by clause understanding of ISO 13485:2016, providing an effective solution to meet the comprehensive requirements of an effective QMS.
TRAINING
OTHER COURSES
Creating and Maintaining Technical Files and Design Dossiers
Designed to support manufactures by confirming current regulatory requirements of technical documentation. The aim of the course is to speed the Notified Body certification process and enable manufacturers to sell compliant devices within the European Union. On completion of training you will be able to identify and locate all regulatory requirements and guidance documentation necessary to write procedures enabling the creation and maintenance of compliant technical files and design dossiers.
Medical Devices Risk Management ISO 14971
This course is designed to provide participants with an understanding of the impact that ISO 14971 has on the decision making process at medical device manufacturing firms. This course helps medical device professionals gain an understanding of how ISO 14971 can improve their business and risk management efforts. Participants will also understand how ISO 14971 applies to ISO 13485. The training includes exercises, and participants will have the chance to ask questions about how ISO 14971 and risk management apply to their organizations.
Writing Technical Files for Compliant Devices
Writing Technical Files for Compliant Devices course is designed to support manufactures by confirming current regulatory requirements of technical documentation. The aim of the course is to speed up the certification process and enable manufacturers to sell compliant devices within the European Union. On completion of the training you will be able to identify and locate all regulatory requirements and guidance documentation necessary to write procedures enabling the creation and maintenance of compliant technical files and design dossiers.
Clinical Evaluation for Medical Devices
Clinical Evaluation for Medical Devices course is designed to support manufacturers by confirming the information necessary to demonstrate clinical safety and performance of their product in accordance with the requirements of the European Medical Devices Directive. On completion of training, manufacturers will be able to determine if a clinical trial is required, prepare a clinical evaluation report including literature review and determine requirements for post-market clinical follow-up and post-market surveillance to support continuing compliance.
Post-Market Surveillance and Vigilance
Post-market surveillance including clinical follow-up, complaint and vigilance handling, impacts on all aspects of the Quality Management System. Proactive and reactive sources of information are a regulatory requirement to be incorporated in your postmarket surveillance procedures applicable to all products. Obtaining the right postmarket information will ensure continued compliance with the directives and identify consumer needs enabling continued product development. Post-Market Surveillance and Vigilance course is designed to help you identify the requirements of the European Medical Device Directives, standards and guidance documents to enable effective implementation of a post market surveillance system.
Process Validation for the Medical Device Industry
Process Validation for the Medical Device Industry course has been designed to help manufacturers gain awareness of quality requirements regarding validation and the nature of “special processes”. Learn the generally accepted principles of validation, and introduce how-to-do methods of installation, operational, and process qualification