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Risk Management Training Courses
19 training items found
by:EuroQuest based inAtlanta, GEORGIA (US) (USA)
In so doing participants will review the new 2003 standard from an auditor’s perspective, highlighting the changes from the former version. In addition, the concepts of ISO 14971 - The Medical Device Risk Management Standard - will be ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
For example companies should be compliant to 14971:2007. Design History Files need to be updated to meet current standards. The FDA expects risk management to be integrated into the company quality system. Old medical devices need to have a risk assessment for each product and updated validations for product and processes. Each product needs to ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
This comprehensive training package of 7 courses is aimed at helping companies to be compliant and streamline the robust supply chain planning, processes, risk management etc by maintaining regulatory guidelines. Implementing Robust Supply chains for life-sciences companies are important now and growing in importance as device manufacturers outsource products and ...
by:Bizenius Business Solutions Pvt. Ltd. based inBangalore, INDIA
The economic and operational stresses caused by the Novel Coronavirus (COVID-19) are highlighting the need for regulated financial institutions to formulate responses to address significant business disruptions (SBDs) and to revisit and enhance their business continuity plans (BCPs). Consumers' use of mobile and online banking has skyrocketed during the coronavirus pandemic as banks have limited ...
Manufactured by:Winncare Group based inPresteigne, UNITED KINGDOM
The 2007-47 European Directive amended Directive 93-42 by introducing 2 new important concepts for medical devices (MD): the medical device user profile, the user environment for the aforesaid ...
by:Quality Management International, Inc. (QMII) based inAshburn, VIRGINIA (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 ...
by:Develop Training Limited based inSwindon, UNITED KINGDOM
Course for electrical staff who are to be nominated for competent persons duties required by HTM's. Learners should have a firm understanding of basic electrical principles. The course is also relevant to works managers and supervisors as an introduction to electrical safety and the ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (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, Medical Device Reporting, and Corrections and Removals (Recalls). This ...
by:NetZealous LLC based inFremont, CALIFORNIA (USA)
Surgical instruments, given the nature of their use, are extremely important devices of the medical industry. That they come with the highest and most stringent quality standards goes without saying. Our in-depth experience in the medical devices industry makes us the ideal provider of trainings on any aspect of surgical instruments, which are a part of the medical device industry. Like all our ...
by:DNV GL - Business Assurance North America based inKaty, TEXAS (USA)
Managing Infection Risk (MIR) Workshop is a comprehensive overview of the framework underpinning the MIR standard as well as the proactive risk assessment methodology used in its development. ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (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 ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (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 regulatory environment, medical device manufacturers often find that the road to compliance can be ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (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 ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
This comprehensive training package is aimed at helping medical device companies ensure that their supply chain controls and manufacturing processes comply with existing regulations. This comprehensive training package is aimed at helping medical device companies ensure that their As manufacturing becomes increasingly global, with responsibility for various parts of the final product vesting with ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
This comprehensive training package of 8 courses is aimed at helping medical device companies ensure that their supply chain controls and manufacturing processes comply with existing ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
This medical device software development, verification and validation training package of four courses covers wellIEC 62304 requirements and explains risk based approach for validation using validation protocols and GAMP®. Medical device software can make or break a device. Badly developed, non-compliant software can compromise a device's safety and reliability. These four webinar recording ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
This pack of 4 courses contains some of our best selling Medical Device webinars which together cover the essential compliance challenges faced by Medical Device companies ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
Medical devices cannot be shipped to Europe unless they are in full compliance with the European Medical Device Directive (MDD). The compliance requirements vary, depending on the classification of the device. It's not just the CE marking requirements that manufacturers and exporters have to worry about, but also the way the MDD is linked to the EU Clinical Trial Directive and ISO Certification ...
by:ComplianceOnline based inSan Jose, CALIFORNIA (USA)
This comprehensive training package of ten courses is aimed at helping medical device companies gain a thorough understanding of the top 10 regulations that they should comply ...