ISO 13485 Consulting (with or without CMDCAS):

Gap analysis audits - Regulatory Progress Associates (RPA) will conduct an audit to determine your current level of compliance with ISO 13485. We can do this with or without the Canadian Medical Devices Conformity Assessment System (CMDCAS). 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. 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.


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