If your company has a pending FDA inspection or ISO 13485 assessment and you would like some support throughout the process, Regulatory Insight can provide that support. We have participated in scores of FDA inspections and ISO 13485 assessments, facilitating the process before, during and after the inspection or assessment. Our participation in FDA inspections and ISO 13485 assessments has frequently resulted in avoiding written non-conformances due to misunderstandings or misinterpretations by the respective agency of a company’s implementation of the requirement of the Regulation or Standard. This can save your company unnecessary time and resources to address non-conformances cited in your FDA inspection or your ISO 13485 assessment that can be avoided through timely clarification. Regulatory Insight’s on-site real-time clarification of such issues has directly resulted in reducing the number and severity of potential non-conformances cited for numerous clients. This can be critical to the outcome of your assessment or inspection, even so far as preventing more serious regulatory action such as issuance of a Warning Letter by the FDA or the non-issuance of your ISO 13485 Certificate. If you have already had your FDA inspection or ISO 13485 assessment, Regulatory Insight can assist your company to write the response, to develop and implement the corrective actions and to subsequently audit your corrective actions to assure that they are appropriate and effective.