Medical Device Industry Training
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by Kelmac Groupbased in IRELAND
This course aims to provide learners who have an existing, basic knowledge of, or experience in, quality management in the Medical Device Industry and in the context of the requirements of ISO 13485, compatible with ...
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based in USA
When medical device nonconformities occur, peoples' lives are often at stake. Consequently, the medical device industry is one of the most heavily regulated, and product and process compliance is a primary objective for all quality management systems for medical ...
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based in USA
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. ...
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based in USA
requirements, ISO 13485:2016 focuses on the entire supply chain of the medical device industry, with added emphasis on risk management. By attending, you'll be able to identify the gaps in your current QMS and start planning your transition and certification to comply with ISO ...
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by EuroQuestbased in USA
This three-day program is designed for quality professionals with a knowledge of medical device manufacturing. The objective of the course is to teach, through lectures, workshops and exercises, how to plan, conduct and report internal audits that are compliant for the medical device industry. In so doing ...
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based in USA
The following is a pack of 8 best-selling training CDs for regulatory professionals in the Medical Device industry. These courses provide information on how medical device companies can achieve compliance in the important stages of device development, marketing and ...
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based in USA
The following is a pack of 3 best-selling training CDs for regulatory professionals in the Medical Device industry. These courses provide information on how medical device companies can achieve compliance with the EU Medical Device Directive, obtain CE marking and fulfill ISO ...
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based in USA
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 ...
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based in USA
The following is a pack of 5 best-selling training CDs for regulatory professionals in the Medical Device industry. These courses provide information on how medical device companies can achieve compliance in the important stages of device development, marketing and maintenance. In today's complex ...
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based in USA
The following is a pack of 4 best-selling training CDs for sales, marketing & regulatory professionals in the Medical Device industry. These courses provide solutions for all critical challenges & questions faced by you and your team pertaining to regulations/compliance, best practices, etc. ComplianceOnline has created these ...
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based in USA
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. ...
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based in USA
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, ...
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by IMSM Ltdbased in UNITED KINGDOM
ISO 13485 specifies requirements for a Quality Management System for organisations required to demonstrate its ability to provide medical devices that consistently meet client and regulatory ...
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based in USA
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 ...
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based in USA
Computer system validation and risk-based verification and validation planning to meet US FDA and ISO 13485 ...
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based in USA
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 ...
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based in USA
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 ...
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based in USA
ComplianceOnline has created these courses individually through world renowned experts and combined them together to create a comprehensive training resource for companies to train their employees. You can store it as a library material and train all your employees in these compliance issues to get them ready to face any kind of compliance challenge and overcome it through expert advice and best ...
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based in USA
This Medical Device Software Development & Management package training will have 4 courses which covers FDA's Medical Device Software Regulation, Medical Device Software Verification and Validation, IQ / OQ / PQ Approach and IEC ...
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based in USA
The main purpose of stability program is to evaluate a shelf life for a product to enter a market and before that determine a safe stability profile during clinical trial. There are many guidance which showcase the best practices how to achieve a successful stability program and then specific guidelines are formulated for a particular product ex – ICH regulatory guidance, QBD, PQS, ...
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