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Consulting, Training, and Auditing Services for

Medical Device, Biotech, and Pharma Companies


Companies developing software for medical devices or using software as part of their manufacturing process often must comply with FDA regulations, guidance documents, and standards from organizations such as ISO, IEC, and AAMI.

I have been actively working with medical device, biotech, and pharmaceutical companies since 1990. By attending conferences, often as a speaker or trainer, and through membership in organizations such as AAMI and ASQ Biomedical Division, I remain abreast of emerging trends and proposed changes to regulations, standards, and guidance documents.

Working collabratively with your staff, I can help increase the effectiveness of your organization by:

  • Assessing your procedures for compliance with applicable regulations, guidance documents, and standards

  • Creating flexible processes based on accepted industry practices that can then be tailored to meet the unique needs and constraints of each project

  • Providing customized on-site training in a variety of skills related to software development, software verification and validation, risk assessment, and other topics...

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.


Services provided include:




Regulations and Guidance Documents:

Selected FDA Regulations, Guidance Documents, and Articles...




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