Quality Management System

Understanding your Quality Assurance requirements and building custom solutions adapted to your current and future needs…

We implement Quality Management Systems and customized services that meet each of our client’s specifications and help to achieve compliance to the following standards:

  • ISO 13485:2016 – Medical devices Quality Management Systems
  • MDSAP Requirements in all MDSAP participant markets
  • 21 CFR 820 Quality Management Systems
  • ISO 9001 Quality management Systems
  • ISO 15189 Medical laboratories
  • ISO 17025 General requirements for the competence of testing and calibration laboratories
  • ISO 22716 Cosmetics Goods Manufacturing Practices (GMP)

We also offer a full range of services, leading each time to the implementation of a customized
quality assurance system, including the following:

  • Gap analysis (existing system vis-à-vis ISO 13485), MDSAP requirements and FDA Quality Systems Regulations
  • Implementation of quality systems ISO 13485 FDA Quality Systems Regulations
  • MDSAP Internal and GAP audits
  • Development of your Standard Operating Procedures (SOP’s)  and Quality Manuals
  • Audit Preparations (Mock Audits)
  • Functioning as a virtual REG/QA department, including onsite staffing
  • Supplier Qualification and Audit
  • Selection of certification body auditors