ISO 13485 MEDICAL DEVICE MANAGEMENT SYSTEM

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 We start by creating a certification agreement that defines the   scope, timelines, and terms for your ISO 13485 Medical Device Management System registration. Once the agreement is  signed, you'll be provided with  information regarding system standards  and guidelines.  

Our team will be in contact with you to start scheduling the audit certification process. Information will be gathered regarding   operations and procedures to help understand your business, this helps  plan a staged audit approach customized to your needs.  

Our services support medical device manufacturers in optimizing quality and regulatory infrastructures, strengthening compliance and data protection, and improving cost efficiency through expert, business-specific recommendations. 

The detailed ISO 13485 certification audit takes place on-site.    We assess the effectiveness of the information security management  system by reviewing documentation, observing processes on-site, and  conducting interviews with employees.  

Once the auditors have submitted their reports to our Registration group for secondary review, we issue your ISO 13485 certificate. Your business will be recognized in our register of  certified organizations.  

Throughout the 3-year certification period, we arrange annual   surveillance audits to ensure your information security management  system continues  to comply with ISO 13485 medical device standards.