Quality Assurance

Quality assurance is one of the most important areas in any project and ongoing activity. In R&D, QA is the last frontier before production and live operation, and should be done with full attention to details along with viewing the full picture, and as a flawless and precise process. We at R.S NESS Group take into consideration the QA during the engineering, planning and characterization stages, by creating the proper documentation, writing the test cases and making sure that all user scenarios are covered, and all system tests are performed properly. We see the full cycle of a product from the start, and our vast experience, out of the box thinking and overall view of the system in an operational environment enables us to plan and execute QA activities in the best and optimal manner.

As part of our QA approach, we work together with the R&D teams, engineers and product managers, to reach the mutual goal of highest quality products and outputs, while ensuring that your requirements are fully met.

Our expertise and activities in the Quality Assurance area are:

Management Systems according to ISO9001: 2015, ISO13485: 2016, 21CFR820, Q10

  • Establishing, implementing and controlling QMS
  • Documentation
  • Risk Management, from planning to RMR
  • Quality audits (both internal and external)
  • Preparing and representing the company for regulatory organization toward third party quality audit
  • Routine management of QMS elements – Deviations/NC’s, MRB, CAPA, Change management
  • Training
  • Supplier control
  • Quality Control management
  • Design control (DHF management, Sterilization process development, V&V support, product realization including CTQ establishment, control and monitoring, traceability)
  • Shelf life and stability studies management
  • Validation activities and consultancy
  • Traceability Matrix establishment and control
  • Quality Assurance for medical application software
  • Packaging and labeling expertise, including design and clinical requirements
  • Extensive experience with all types of sterilization (steam, Gama, Gas, Chemical)
  • Shipping and storage quality assurance and consulting
Quality Assurance, project management mdr quality management system for Life Science companies - RS NESS