Quality Management System Certification

We provide certification and assessment services for various Quality Management System (QMS) standards, ensuring regulatory compliance and operational excellence. Our certification schemes include:

🔹ISO 9001 – Quality Management System Certification
🔹ISO 13485 – Medical Devices Quality Management System Certification
🔹Good Distribution Practice for Medical Devices (GDPMD) Certification
🔹Conformity Assessment of Technical Documentation
🔹Conformity Assessment by Way of Verification

Training Services for the Medical Device Industry

Our expert-led training programs cover essential topics in medical device manufacturing, regulatory compliance, and personnel competency development. We offer:

🔹ISO 13485 & ISO 9001 Internal Audit Training
🔹GDPMD Training (Understanding, Internal Audit & Clause-by-Clause)
🔹Medical Device Risk Management (ISO 14971)
🔹Manufacturing Process Validation for Medical Devices
🔹Biocompatibility Training
🔹Sterilization Training (Gamma Irradiation, EtO, Steam, Dry Heat)
🔹Medical Device Single Audit Program (MDSAP)
🔹EU MDR 2017/745 Compliance Training
🔹ISO 19011 Internal Auditing for Management Systems
All of our training courses are HRD Corp claimable.

Regulatory & Compliance Support

We support organizations in meeting national and international medical device regulations by facilitating compliance and ensuring adherence to certification requirements.