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Medical Device Production Training Courses
6 training items found
by:COBBLESTONE, a Division of The Center for Professional Advancement (CfPA) based inEast Brunswick, NEW JERSEY (USA)
In the FDA’s Guide to Sterilization Process Controls, the FDA stated five (5) key inspectional objectives which are used by the agency during routine inspections of sterilization and sterility assurance processes. One of the key areas of concern pertains to the production and process control subsystem (including sterilization process controls) which requires that ...
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)
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 developed, non-compliant software can compromise a device's safety and reliability. These four webinar recording ...
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 ...
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 ...