RPA Auditing Services to ISO 13485, US QSR and other systems:

Gap analysis audits - Regulatory Progress Associates (RPA) will conduct an audit to determine your current level of compliance with ISO 13485, US FDA QSR or other services.  The gap analysis is typically conducted before a system is implemented to identify areas of deficiency or can be conducted after implementation to identify deficiencies.

Pre-assessment audits - RPA highly recommends a pre-assessment audit several weeks prior to a certification audit (i.e. ISO 13485). RPA consultants will ensure that you are aware of all non-compliances and deficiencies and will provide a plan for getting your firm ready for your certification audit.

Full or partial internal audits - ISO and FDA QSR (GMP) require that manufacturers conduct internal audits of their quality management systems (QMS) on a routine basis. RPA auditing services will ensure you meet this critical requirement. In addition as a third party we are non-bias and holds much more credibility with regulatory and certifying agencies.

Subcontractor or supplier audits - QMS requirements require control of Critical suppliers. Whether your device is entirely manufactured by a third party or if critical components or services (like sterilization) you can depend on RPA to ensure a thorough audit of the facilities.

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