Omsbar Medical Device Design Manufacturing and Regulatory Services



Medical Device Design Clinical Evaluation Export Certification Project Management Product Registration Quality Management Regulatory Affairs Verification and Validation OMSBAR Contact Information Training Design Manufacturing Omsbar Medical Device Consultancy


Quality Management
  Omsbar can assess and audit existing quality management systems and advise on the specification and structure of new systems or modifications to current systems. Objective auditing will assess the effectiveness of quality management systems within the European Medical Device Directive and the USA Code of Federal Regulations.
 

Audits prior to FDA site inspection are particularly useful for companies outside the USA. Cultural orientation and understanding of FDA-specific requirements are useful for non-US based companies, especially when first entering the US market or preparing for a first site inspection.
  Pre-inspection audits (to assess the current position and suggest system reinforcements in preparation for an investigation), combined with post-inspection work and audits, (to implement and verify any required changes) ensure continuing improvement of quality management.
  Experience with the requirements of USA and European quality management systems help identify areas of commonality and gaps. This is especially beneficial for entry into US and EEA markets from those based outside.