QMS Maintenance Contract
Your Quality Management System and Technical Files need to be constantly maintained and updated. The system must be followed as documented, new standards and regulations identified and implemented, new clinical data continuously collected, and documents like your Risk Management Report, and clinical and post-market surveillance documents need constant repair and revision.
Not doing so can risk the continuation of your product registration.
Once you sign an Annual Contract, our team will:
• Dig through volumes of data to identify useful information to update your reports
• Rewrite your clinical documents, PMS documents and risk management documents.
• Continuously search for updates on standards applicable to you and alert you if anything needs to be done.
• Visit your site and conduct audits prior to external audits
• Help you answer queries from regulatory authorities that you may get during audits and vigilance activities.
Our Packages
Platinum
- Update selective technical file documents
- Conduct internal audits and keep the QMS up-to-date
- Help with queries from regulatory authorities and certification bodies
Gold
- Update selective technical file documents
- Conduct internal audits and keep the QMS up-to-date
