FDA is enforcing compliance with the Regulations more so than ever before. If your company has just received a Form FDA-483 containing inspectional observations, there is no need to panic; however, you should act quickly and appropriately to head off potential further regulatory action. FDA’s recent policy is that companies must provide a written response within 15 days of receiving a Form FDA-483 or further risk receiving a Warning Letter. Regulatory Insight can help to quickly assess the situation and assist your company to write a balanced response that demonstrates your company’s commitment to full compliance, yet is not overly burdensome and beyond the requirements stipulated by the Regulations. If you have received a Warning Letter, Regulatory Insight can quickly, yet thoroughly, assess the situation and assist you to write the response. We can also accompany your Senior Management to a face-to-face meeting with your FDA District Office, which is essential any time a company receives a Warning Letter from the FDA in order to show Management’s commitment to getting the company quickly back into compliance. If you have received your ISO 13485 Assessment Report and it contains non-conformances, you must provide your Notified Body / Third Party Registrar with a corrective action plan for addressing the non-conformities. Regulatory Insight can assist your company to devise corrective action plans that meet the spirit of the ISO 13485 Standard without committing your company to unnecessarily onerous tasks that may have little relevance to the quality of your products or the ISO 13485 Standard. Once your corrective action plan has been accepted by the issuing regulatory body, Regulatory Insight can assist your company with implementing the corrective actions and auditing them afterwards to assure that they have been properly implemented, are effective, and have not caused other new unforeseen problems.