Let us help you develop the right structure and programs to meet the essential elements of a Quality System, whether Medical Devices or Pharma/Biotech or a Combination Product.
Quality Management System: Understanding organizational needs, regulatory requirements, short and long term planning, QMS development, IT alignment, KPI/Metric development, Management responsibilities
Risk Management: initial concept into post market activities: Managing the Benefit Risk Profile of your products. Starting with the design of the product, to understanding critical manufacturing processes to control your product and finally developing the sensitive tools for post-market surveillance.
Deviation Management/CAPA: Risk based approach for investigations: Allowing for prioritization and consolidation of investigation, enabling focused investigation on what is critical to your organization. Resulting in better utilization of resources and reduced cycle-time to Correction, Corrective Action and Preventative Action implementation.
Audit/Inspection support: Assessing current organization; to regulatory prep and inspection support, to communication, remediation planning. We have the experience to minimize inspection finding(s) through aligning cross-functional organizations and processes to meet/exceed regulatory compliance. The key is to be always Inspection Ready. Our unique approach to processes and people will enable your organization for the ‘knock on the door’ or that 3AM phone call.
Supplier Quality: Starting from product development, qualifying suppliers, audits, supplier listing maintenance, recall support, management communication on critical vendor performance. Click here for more information on how we can assistance your supplier quality program