Medical Equipment Training
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ISO 13485:2016 Auditor Refresher Training Courses
Are you an existing auditor with knowledge of ISO 13485 wishing to update your audit programme in line with ISO 13485:2016? This course will refresh your auditing techniques and help you prepare to audit against requirements. With a transition period of 3 years, it's important to get up to speed so you can ensure your organization is ready to comply with new requirements. Through audit scenarios, ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line
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BSI - ISO 13485 Quality Management System Software
Medical device manufacturing is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose. The ISO 13485 standard is an effective solution to meet the ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA).
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ISO 13485:2016 Senior Management Briefing Training Courses
As a leader, your commitment and support is crucial to the success of your organization's ISO 13485:2016 Medical Devices Quality Management System (QMS). This interactive briefing has been designed around the requirements of the standard and highlights your responsibilities in terms of leadership and commitment. The focus is on helping senior management migrate their system from ISO 13485:2003 to ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line
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ISO 14971 Medical Devices Risk Management Training Courses
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 one-day training 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 ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - Specialist Training Training line
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Performance Evaluation and Clinical Evidence for IVDs Training Course
If you are involved in planning, conducting or documenting performance evaluation and clinical performance studies for IVD devices in Europe, this intensive one day course will enable a greater understanding of performance evaluation for In Vitro Diagnostic devices under the IVD Regulation, how performance fits into the product development lifecycle and IVD Regulation (IVDR) requirements for ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - Specialist Training Training line
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Implementing ISO 13485:2016 - Training Courses
You'll be introduced to the concepts needed to understand, develop and implement a Quality Management System (QMS). This course provides the knowledge and process steps to enable the effective implementation of a QMS that is in line with the requirements for ISO 13485:2016 ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line
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Understanding ISO 14971:2007 Training Courses
BSI's "Understanding ISO 14971:2007" course is designed to provide participantswithan understanding of the impact that ISO 14971:2007 has on the decision making process at medical device manufacturing firms. This one-day training course helps medical device professionals gain an understanding of how ISO 14971:2007 can improve their business and risk management efforts. Participants will also ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - Specialist Training Training line
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Introduction to ISO 13485:2016 Training Courses
This course explores the requirements of the ISO 13485:2016 Quality Management System standard, discussing key principles and how the standard interacts with ISO 9001:2015, the European Medical Device Directives and US FDA's Quality System Regulation. The relationship with ISO 14971 “Application of Risk Management to Medical Devices” is also explored during the course. ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line
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IVD Directive to IVD Regulation Transition Training Course
There are significant changes in the European legislation applicable to IVDs. The IVD Regulation has replaced the IVD Directive, which will impose new requirements on manufacturers and other economic operators. By attending this course, you’ll discover the new requirements and how these will affect your organization. ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - CE Marking Training Training line
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Medical Device Directive CE Marking
BSI's “Medical Devices CE Marking” three day course is designed to provide participants with the knowledge to assist their companies in getting products to market more quickly. Management personnel responsible for all aspects of CE marking medical devices as well as internal and external auditors will benefit from this course. Participants will gain knowledge of the requirements of ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - CE Marking Training Training line
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Transition and Auditor Refresher Course from 13485:2003 to 13485:2016 Training Courses
With greater attention on the organization's ability to meet applicable customer and regulatory requirements, the new ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management. Discover the latest requirements and explore the changes since ISO 13485:2003 and EN 13485:2012. You'll refresh your auditing techniques and be able to ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line
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ISO 13485:2016 Transition Training Courses
Are you already familiar with ISO 13485:2003/EN 13485:2012 and want to find out about ISO 13485:2016? This comprehensive course introduces you to the new requirements and explores the changes between ISO 13485:2003/EN 13485:2012 and the latest standard. With greater attention on the organization's ability to meet applicable customer and regulatory requirements, ISO 13485:2016 focuses on the ...
By British Standards Institution (BSI) based in Herndon, VIRGINIA (USA). from Medical Device Regulatory Training - ISO 13485 Training Training line
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Healthcare Science Audiology Course
Accredited by the National School of Healthcare Science (NSHCS) allowing graduates to be eligible to practice in the ...
By De Montfort University (DMU) based in Leicester, UNITED KINGDOM. from Full Time Courses Training line
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Training
Our progress is possible thanks to the joint work and commitment of professionals willing to share their knowledge and experience in order to train distributors and medical professionals. These training programs are backed by the highest quality standards, in order to guarantee the efficient and safe implementation of our ...
By Tecme based in AgustÃn Tosco, ARGENTINA.
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Covartim - Trainings
We are here to support our clients but also to strenghten their team. We aim at helping them become autonomous and take control of their progression. For this purpose our specialists have developed a comprehensive training program on key ...
By Covartim based in Watermael-Boitsfort, BELGIUM.
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SI Joint Fusion System Training
Our hands-on training provides you with a thorough understanding of the diagnosis and treatment of SI joint pain. If you are interested in being trained to use the SI-Cure or Re-Live Implants, ...
By Alevio, LLC based in Birmingham, ALABAMA (USA).
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Training
The C-Arm is the most versatile radiological product on the market. It is used in all operating theatres, for endoscopy, cardiology, pneumology, emergency care applications and in ever growing ...
By SIMAD s.r.l. based in Bologna, ITALY.
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EMS - Cardiac Care Training
From cardiac wheezes and chest pain to stroke care and ventricular assist devices, you need to be prepared for any cardiac-related medical emergency. These courses will help you keep up to date on cardiac ...
By EMS1 based in Lakeland, FLORIDA (USA). from EMS Training Training line
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Pack of two courses: The essentials of Food and Drug Administration Medical Device Regulations: A primer for manufacturers and suppliers
This pack of 2 courses contains the essentials of FDA Medical Device regulations. In the United States, the US Food and Drug Administrates Medical Devices through several different regulations, the principle one is the Quality System Regulation 21 CFR 820 (QSR). Other regulations include Registration and Listing, Labeling, Medical Device Reporting, and Corrections and Removals (Recalls). This ...
By ComplianceOnline based in Palo Alto, CALIFORNIA (USA). from Medical Devices Training line
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21CFR Part 11 and Harmonization with 21 CFR Part 812 for Medical Device Trials
Conducting clinical trials in a rapidly evolving electronic environment presents a unique challenge to the medical device industry where not only quality (GLP/GMP) plays an essential role – but collecting accurate, maintaining viable data (GCP) as part of continuous process improvement (while mitigating risk) is an essential and critical component of the development paradigm. The complexity ...
By ComplianceOnline based in Palo Alto, CALIFORNIA (USA). from Clinical Regulatory Compliance Training Training line
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