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Identifying, developing and implementing the best solution for your organization is paramount.

Tailoring and applying the guidance provided by 21CFR§820, ISO13485, ISO14971, IEC 62304, CMMi and other Design Control processes and "Best Practices" will provide you with a roadmap that not only makes strategic sense but also results in exceeding customer expectations.

Using published external guidance, industry best practices and trends along with your existing internal Quality Plans, Policies, Procedures and supporting Training, we will develop and implement living processes.  

Internal audits are conducted to validate and verify desired compliance.