QMSPROF SERVICES
Professional Consultation and Training Provider
With over 20 years experience in management system development, auditing and training with proven track records for small and medium company until multi-national company that lead to achieving ISO certification, regulatory compliance, human resource development and improvement for business and market needs
Service and System that We are Best for
ISO 13485:2016
ISO 14971:2019
MDSAP
Training
GDPMD / GDPMDS
EU CE MDR
ISO 9001:2015
Medical Device Registration
About Us
Over 20 Years experience in provide Consultancy and Training Service in Quality Management System (ISO) and Regulatory Services for Medical Device Industry.
Our customers proudly achieved 1st attempt Certification Audit without critical or major findings (for ISO 13485 and GDPMD QMS) and granted certification from reputable Notified body / certification body
Successful registered of medical device in main global country (included EU, US, SEAP – Malaysia, Singapore, and more…)
Trained more than 3500 industrial experts (from non-skill personnel to skilled personnel) and top management in achieving competency requirements to meet QMS and regulatory requirements
Expertise
01. Quality Management System
- Documentation Development
- Implementation Advise
- Internal Auditing & Gap Assessment
- Improvement Guide
02. Training
- Awareness
- Auditing
03. Medical device registration
- Technical Documentation
- Registration Submission
04.Others services
Certification Audit Support
