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Medical Device Management Training Courses

8 training items found

Medical Device Management Systems and ISO 13485 / ISO 14971 Training

Medical Device Management Systems and ISO 13485 / ISO 14971 Training

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 ...
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Apex - IATF 16949:2016 Internal Auditor Exemplar Global Recognized Training

Apex - IATF 16949:2016 Internal Auditor Exemplar Global Recognized Training

by:Apex Quality Assurance   based inHampstead, NORTH CAROLINA (USA)
Although the ISO 9001 requirements have been removed from IATF 16949:2016 and are published as a separate ISO standard, IATF 16949 is not a stand-alone standard and must be used in conjunction with ISO 9001, we offer courses that cover both the ISO 9001:2015 and IATF 16949:2016 requirements. Group exercises and case studies with examples from the automotive industry will be used to develop the ...
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ISO 13485 Internal Auditor Training

ISO 13485 Internal Auditor Training

by:EuroQuest   based inAtlanta, GEORGIA (US) (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 participants will ...
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21CFR Part 11 and Harmonization with 21 CFR Part 812 for Medical Device Trials

21CFR Part 11 and Harmonization with 21 CFR Part 812 for Medical Device Trials

by:ComplianceOnline   based inSan Jose, CALIFORNIA (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 critical component of the development paradigm. The complexity ...
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Medical Device Software Development & Management - Comprehensive Training Package (4 Courses)

Medical Device Software Development & Management - Comprehensive Training Package (4 Courses)

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 ...
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EU Medical Device Regulations - Comprehensive Compliance Training Course

EU Medical Device Regulations - Comprehensive Compliance Training Course

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 ...
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Best Selling Medical Devices webinars

Best Selling Medical Devices webinars

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 ...
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Medical Device Software Development & Management - Comprehensive Training Package (4 Courses)

Medical Device Software Development & Management - Comprehensive Training Package (4 Courses)

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 ...
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