Our Quality

Due to confidentiality and proprietary reasons, we are not able to share our qualification and experience of our personals/engineers. However the individual portfolios can be made available during project initiation if requested by client
In general, we have personals and engineers qualified, certified and experienced in the following field:
Registered Engineer with the Board of Engineers Malaysia (BEM)
Registered QMS Lead Auditor with IRCA
TUV SUD Certified Internal Quality Auditor for ISO 13485 : 2003 Medical devices regulatory requirements
Associate Member of the The Chartered Quality Institute, UK – ACQI
Coordination and Factory Management – Japan Association of Manufacturing Analysis
Implementation of 21 CFR Part 820 Quality System Regulation
Cleanroom Requirements Class 100K and on Validations of Computer Software, ETO sterilization, 510 K, Technical File
FDA Guide to Inspections of Quality Systems (QSIT)
ISO 13485 : 2003 and Canadian Medical Devices Conformity Assessment System (CMDCAS) Requirements
European Medical Device Directive /93/42/EEC
ISO 14971:2007 Medical Device Risk Management
Plastic Injection Moulding
Medical Device and Sterile Packaging Validation - ISO 11607
IPEC GMP Training
Project Management, Validation and Technical Development
Vast experience in validation and audit of microbiology labs, sterilization facilities and pharmaceutical labs
 
Our Services
Supplier Audits and Internal Audits
Assessment Activity
ISO System Implementation
Technical Support
Other Services
 
Client Tell
 
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