Policy We believe that the users rely on our high quality products to deliver the desired clinical outcomes of the procedures while safeguarding the patient safety. Our products will always be the trusted tools of the users.
Programme
Rich experienced team with diverse exposures in product design, tooling, plastics and metalwork, industrial engineering and product assembly for quality excellence.
Total Quality Management (TQM) from product conceptualization to post product delivery.
Strict document control for Device Master Record (DMR), Device History Records (DHR).
Compliance to international standards (ISO/CE/NMPA) and Good Manufacturing Practice (GMP).
Consistent Quality Management System (QMS) in place directing our complete operations.
Regulatory Compliance
VHMED follows closely with the latest developments of the regulatory practices globally where we operate. We ensure the compliance of all local protocols stipulated by different regulatory parties by adopting the highest international standards.
ISO 13485:2016 - Quality Management Systems.
CE Certified with MDD 93/42/EEC Conformity.
ISO 14971 - Application of risk management to medical devices.
IEC 60601 - Safety and essential performance of medical electrical equipment.
ISO 10993 - Biological evaluation of medical devices.
ISO 11607 - Packaging for terminally sterilized medical devices.
ISO 14644 - Classification of air cleanliness, testing, measures and controls.
ISO 14698 - Cleanrooms and associated controlled environments - Biocontamination control.
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