Quality Management Services (QMS) – GDPMDS
For companies that import and/or wholesale medical devices, a quality management system and GDPMDS certification will be required to conduct business in Singapore. The quality management system involves numerous procedures as well as providing suitable facilities and staff to handle those medical devices, while keeping accurate and timely records.
Quality Management Services (QMS) are performed in accordance with internationally recognized quality standards such as the ISO 13485 standard for manufacturing and storage of medical devices. Quality assurance activities are focused on auditing a wide range of activities encompassing the day-to-day operations in accordance with applicable standards. A well-designed QMS will ensure consistent product and service quality, enabling an efficient and cost effective business process.
Good Distribution Practice for Medical Devices (GDPMDS) is the implemented standard for ensuring that the quality of medical devices is maintained throughout its distribution journey, enhancing customer satisfaction in supplier-customer relationships. A well-implemented GDPMDS will guarantee that products are consistently stored, transported and handled under suitable conditions, in accordance with the marketing authorization and product specifications. GDPMDS is more than a set of quality manuals. It involves practical procedures, qualified personnel, well-maintained facilities/equipment and consistent maintenance of records and documentation.
We provide full support in developing and implementing an effective quality management system for the distribution of medical devices to bring your company in line with the GDPMDS.
We advise companies on the approved certification bodies available and assist in securing a competitive quote. We assist companies in having standard operating procedures that bring your company’s operations in line with the GDPMDS standards. Through internal audits and management reviews that we conduct, lapses in the processes will be rectified. Our unique templates enable easy recording of necessary data, helping your company address any findings or non-conformities upon a post audit, if any.
We work hand in hand with your company from the beginning till a successful certification is attained, including training your staff in the various aspects of GDPMDS to ensure smooth implementation of standards. Subsequently, we will guide your company to apply the relevant licenses i.e. importer & wholesaler licenses, Company Registration for e-Services (CRIS) account upon successful certification.