ISO 13485 is used as a regulatory standard and thus it is crucial that certified organizations remain in conformance. Errors with your system can cause regulators to issue fines and penalties or even cause you to stop business. Thus internal auditing needs to be very good. It need to find any issues before the regulators and it needs to provide solutions that are practical and yet still meet the requirements.
We have been auditing medical device organizations for 25 years and has devised auditing approaches that are precise and ensure that all requirements can be carefully examined for conformance. Substantial and broad experience with management systems allows us to provide feedback about streamlining and improvement.
Our reporting contains clear objective findings quantified and supported by evidence to give management a clear understanding of problems and risks associated with regulatory compliance. Fixing these findings will basically take care of the regulatory posture of the organization. We also provide subjective findings, also supported by evidence where we make recommendations for improvement, streamlining and strengthening conformance.
We audit against ISO 13485, FDA QSR and EU In-Vitro and Medical Device Directives and Canadian CMDCAS regulations. We are thorough, professional and precise. Our audits relieve you of the difficulties of resourcing these audits internally and getting good results. We provide clear assurance to let management rest easy that the organization will remain in compliance with regulatory requirements. Contact us for more information about giving you that assurance.