Elite provides gdpmd training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
Elite provides gdpmd training and consultancy services. We offer specialized expertise and extensive practical experience to assist client in developing management systems from the initial concept to establishment and successful implementation of the management systems.
We use the following consultation approach to assist you in achieving certification:
With the effective date (1 July 2013) of Act 737 and Medical Device Regulations 2012, manufacturers and distributors of medical devices are required to apply for their establishment licence to continue carrying out their manufacturing, distribution or importing activities.
Manufacturers require ISO13485 Medical Devices Quality Management System certification whereas Distributors, Importers and local Authorized Representative require Good Distribution Practice for Medical Devices (GDPMD) certification prior to applying for their Establishment Licence.
GDPMD requirements consists of 6 parts:
Benefits of GDPMD
We are an organization specially established to provide consultation, training and technical support services in all aspects related to management system. As one company offers process, technical and system focused management expertise, we maintain good track record in the field of:
Nevertheless, we are always committed to deliver, and continue to deliver highly customize solution that fulfill your needs.
Our professional team has a wealth of experience in the application of management tools and techniques in a wide range of manufacturing and service industries.
We believe that the ability of being able to offer our clients long-term support is very important. Our philosophy is to design and establish a management system that is not only compatible with each client’s company culture but also comply with the International Standard requirements. We guarantee our client’s satisfaction by achieving certification in the most effective and efficient manner at optimum cost.
When you choose to use our services, we take our responsibility to you seriously – as a partner, not an invigilator, as a cipher to success, not a slave to documentation. You will always be assured of responsive, positive approach to your business. After all, your success is our success.
Business ethics
Quality policy
Benefits
Consultation Approach
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