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Medical Device Development Training Courses
6 training items found
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: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)
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 ...
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 ...
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 ...