ISO & QMS Certification

We help businesses meet global standards and follow regulations with our QMS certification and assessment services. Our goal is to make compliance simple and achievable, while improving your operations.

Our certification programs include:
🔹 ISO 9001 – Quality Management System Certification
🔹 ISO 13485 – Medical Devices Quality Management System Certification
🔹 GDPMD – Good Distribution Practice for Medical Devices Certification
🔹 Conformity Assessment of Technical Documentation
🔹 Conformity Assessment by Way of Verification

Medical Device Training

Our training programs are led by experienced industry professionals. We focus on giving you the knowledge and skills needed for medical device manufacturing, meeting regulatory requirements, and developing competent teams.

We offer:
🔹 ISO 13485 & ISO 9001 – Internal Audit Training
🔹 GDPMD – Understanding, Internal Audit & Clause-by-Clause Training
🔹 ISO 14971 – Medical Device Risk Management
🔹 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 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.