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Training Services for Biotech and Medical Device Companies


Companies developing software in regulated industries must maintain compliance with regulations such as the FDA Quality System Regulation as well as standards from organizations such as ISO, IEC, and AAMI.

Examples of on-site workshops, tailored to meet your specific needs, environment, and products, include:
  • Software V&V

    Practical skills to increase effectiveness of software verification and validation.

  • Risk Assessment and Hazard Analysis

    Learn to perform Risk Assessment for software-based medical devices. Ensure compliance with ISO 14971 and take advantage of AAMI TIR-32 Application of Risk Management to Software-based Medical Devices. Learn effective techniques such Fault Tree Analysis (FTA) and Failure Mode Effects Criticality Analysis (FMECA).

  • Computer System Validation Training

    Perform effective validation of computer systems used in Manufacturing and Quality Systems.

  • 21 CFR Part 11 Trainingg

    Learn how to comply with regulation on Electronic Records and Electronic Signatures.

  • Process Validation Training

    Perform effective validation of processes used in Manufacturing.

Let my experience in software engineering, medical device software development, training, and auditing, help identify those aspects of your development process that need to be brought into compliance with the regulations and standards.

Working collabratively with your staff, we develop processes that not only are compliant but are also cost-effective and make make good business sense... This approach provides the best return on investment.




For further information,

call Steve Rakitin at 508.529.4282

or e-mail him at steve@swqual.com


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Copyright ©2008 Software Quality Consulting, Inc. All rights reserved.

Updated January 2008