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Training Services for

Medical Device, Biotech, and Pharma Companies


Companies developing software for use as part of a medical device or who are using software as part of their manufacturing, production, or quality systems must maintain compliance with FDA regulations, guidance documents, and standards from organizations such as ISO, IEC, and AAMI.

On-site training can provide your staff with the tools and techniques they need to be more productive and to produce products that are safer, more reliable, and more cost-effective.

On-Site Workshops for Medical Device, Biotech, and Pharma Companies

Each of the workshops below can be tailored to meet your specific needs and all are based on the simple principle that real learning occurs when people are actively engaged.

Call for information on tailoring these workshops to your Quality Management System...

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

Working collabratively with your staff, we can develop compliant, cost-effective processes that can help achieve your critical business objectives. 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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Updated March 2008