Lexium offers highly knowledge based cost effective training programs to keep Regulatory /QA professionals ahead of the ever changing Regulatory landscape. Lexium training courses are highly interactive and based on real scenarios and designed to meet your specific training needs.

With the flexibility to deliver courses at your location ,off site or on line our customized courses cover a broad range of relevant technical Topics.

Some of our main Training Courses are listed below :

ISO 13485 : 2016 Training Courses

• Introduction to ISO 13485:2016
• Implementing ISO 13485:2016
• Internal Auditor ISO 13485:2016

European CE Marking Training Courses

• Requirements for the EU medical device regulation (MDR/745)
• Implementation of medical device regulation MDR for CE marking
• Implementation of In vitro diagnostics regulation IVDR for CE marking

FDA

• USFDA regulation for Medical devices
• Country specific medical devices regulation

Medical Device Testing / Risk Management

• Medical device risk regulations ISO 14971 : 2019
• Biocompatibility Testing ISO 10993-1
• Safety and EMC/EMI Testing IEC 60601-1/IEC 60601-1-2

Call us today for your specific training needs

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