Our Quality Division will support you in implementing or improving a quality management system for your company or manufacturing site. Competition demands a high quality standard for medical products and compliance with regulations.
Our Quality Division will support you in implementing or improving a quality management system for your company or manufacturing site. Competition demands a high quality standard for medical products and compliance with regulations.
ISO 13485:2016.
ISO 9001:2015.
ICH Q10.
NOM-059-SSA1-2015.
NOM-241-SSA1-2021.
FEUM 5th Edition.
Initial evaluation.
Analysis of deficiencies.
SOP documentation, creation, implementation and training.
Second evaluation.
Corrections of findings of the Quality Management System.
Audits for suppliers and distributors.
Internal audits to verify quality compliance.
GXP's.
Auditor Qualification Program.
Interpretation and implementation of Quality standards.
Preparation of personnel qualification protocols.
