reginsight

Description

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.

If your company is based outside the U.S. and your medical devices are being imported into the United States, your company must also be registered with the FDA as a manufacturer, foreign exporter or other type of establishment, as applicable. You must also list your devices with the FDA, and you must assign someone residing in the United States to act as your company’s U.S. Agent (please see our U.S. Agent Page ). Regulatory Insight can register your company, list your devices with the FDA, and act as your company’s U.S. Agent.

There is no getting around it – training is a requirement of your Quality System. If your company does not have in-house training personnel, you need to find another way to provide quality systems training to your employees. One option is to send your employees to seminars; however, most seminars only cover certain aspects of the FDA Quality System Regulations and/or ISO 13485 Standard.

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