Services

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Experience in assisting companies to implement a quality management system to obtain and sustain an ISO 13485 certification, which is in alignment with the FDA Code of Federal Regulations, Title 21, sub-chapter H - Medical Devices Part 820 Quality System Regulation. 

Auditing is a prescribed work practice or process. Audits must be prepared for by planning ahead, then performed by a experienced auditor within the field of your organization. Quality13485 specializes in the medical device industry providing professional audit assessments to determine whether agreed upon requirements are being met.