A well executed system drives excellence, bringing your business processes under control and giving you the information you need to drive continuous improvement.
We will work with you to implement and develop ownership of a Quality System that is fit for purpose and is compliant to both ISO 13485 and the US FDA 21CFR 820 “Quality System Regulations”. We can also advise on more specialist GxP requirements, including ISO 17025 GLP and specialist quality systems for clinical laboratories and for R&D facilities or design houses.
We can help you with:
Implementation or upgrade of systems for:
- Medical Devices & Quality Management: ISO 13485
- Testing & Calibration Competency: ISO 17025
- Electronic Documents and Laboratory Notebooks: FDA 21 CFR 11
- Medical Testing: ISO 15189
- Design Control: FDA 21CFR 820:30
- Physical Containment Certification PC2, PC3
Aculeate : sharp thinking in business