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Auditing Services for

Medical Device, Biotech and Pharma Companies


Companies developing software as part of a medical device or using software as part of a manufacturing, production, or quality system are required to maintain compliance with FDA regulations, guidance documents and standards from organizations such as ISO, IEC, and AAMI.


Auditing Services

Properly planned audits can identify gaps in your present quality system and opportunities for improvements.

Examples of typical audits include:


  • Design Controls Compliance Audit

  • Part 11 Compliance Audit

  • ISO 13485 Compliance Audit

  • ISO 14971 Compliance Audit

  • Quality and Process Audits

Each audit begins with an Audit Plan that identifies what, when, where, and who. The Audit Plan is reviewed and approved prior to the audit. Members of the client's staff are encouraged to participate on the Audit Team. Once the audit is completed, an Audit Report is prepared, and if requested, a detailed "gap analysis" is provided.

Relevant Audit Experience:
  • ASQ Certified Quality Auditor (CQA) since 1994

  • ISO 9000 Lead Assessor Training

  • SEI CMM Assessor Training

  • Lead Auditor on dozens of audits covering Development and Manufacturing

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.


Click here for brief summaries of past consulting engagements.



For further information,

call Steve Rakitin at 508.529.4282

or e-mail him at steve@swqual.com


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Updated January 2008