Services:

 

Quality Management System Auditing Services:
  • Providing organizations with internal auditing support (full quality / partial quality system audits).

 

  • Performing Supplier audits.

 

  • Conducting Gap Analysis Audits to the Medical Device Regulations (MDDs), FDA Quality System Regulation (21 CFR820), ISO 13485, Japan PAL, and the Canadian Medical Device Regulations (CMD-CAS).

Cost-Effective On-Site Quality Systems Training:

 

  • Providing customized on-site Quality Systems Training (QSR/ISO 13485/CMDR/MDD) for your employees.

Quality Management System Development Services:
  • Providing customized solutions in developing and implementing Quality Systems that comply with global regulatory requirements that meet your business needs.

 

On-going Support:

 

  • Always accessible to provide you with support during your project, both on-site and off-site.