Implementation of ISO 13485 – Pacificare Hong Kong Ltd.

With headquarter in Hong Kong and factory located in China, Pacificare is committed to provide vertically-integrated service from design, R&D, prototyping, in-house mold fabrication to manufacture high quality healthcare and oral care products at competitive price level. Pacific Care have been dedicated to product development and to a steady expansion of the manufacturing facilities.

The need
Pacificare understand that their clients concern very much in identifying a credible and reliable manufacturer who can understand well their needs in Design Control, Project Management, and Quality Control. Pacificare is commited to ensure it's company objective, company culture, people, quality system, and their management system would provide a high degree of confidence to their customer.

The solution
ISO 13485 is the solution for Pacificare. We initiated the project with an simple audit onto the existing management system for Pacificare Limited. Once the gaps had been identified we then offered guidances regarding to the regulatory & ISO 13485 requirements. This allows Pacificare to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices.

The result

“ I would like to offer our sincere gratitude to Mr. Paul Tse of Qualitech Consultancy Limited in providing professional consultancy and training program for our ISO 13485 Medical devices-QMS implementation and certification.”

Miss Chris Kwong – Operation Manager,



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