As efficiency and success typically grow from preparation, mock audits are conducted by experienced and trusted consultants to significantly assist manufacturers, suppliers or sub-contractors in the new era of medical devices. NAMSA has a team of experts that meet daily with authorities and manufacturers to discuss regulations and international standards, how to comply with those regulations and standards to fix gaps.
We have the capabilities to:
- Provide mock audit services of quality system to ensure compliance
- Audit organizations with a special focus on company structure to help companies face unannounced visits
- Perform mock audit of your Technical File or Design Dossier and gap analyze them against current standards and requirements to raise possible areas of improvements
- Review the Risk Management Report and associated documentation according to regulations
- Review Design History Files for compliance with regulations and standards
- Conduct on-site training around requirements and how they shape the organization to ensure good quality and compliance of medical devices
- Review existing key procedures to ensure compliance, including post production procedures and monitoring plans
- Administer temporary staff, fully trained on Quality System Requirements to assist with CAPAs, Internal Audits, Supplier Audits, design controls, management reviews and complaint management
- Provide Technical Specialists to help audit critical subcontractors and/or crucial suppliers
Our experts are available for support in the U.S., China, Japan and Europe; so there is always someone next door to your facility to help you navigating through audits.