SERVICES RENDERED

To provide consultancy on Medical Device regulatory issues.

To provide consultancy services regarding the Medical Device Act 737 requirement and standard that need to be complied by organization.

Assist companies with the required resources so as to help manage the best standards and quality within the regulatory framework of Act 737.

To provide assistance to clients and customers regarding the international standards to be maintained in respective organizations.

To advise establishments of matter under the Act 737 and its subsidiary regulation such as registration of medical device, GDPMD for license of establishment and certification of ISO 13485.

To provide document preparation for GDPMD, ISO 13485 and product registration of medical device.

To provide in-house and public training to the industry. We also provide training that is claimable by Human Resource Development Corporation (HRD Corp).

BENEFITS OF ISO 13485 AND GDPMD CERTIFICATION

Savings in cost from reduction of defects and rejects.

Meet regulatory requirements and customer expectations.

Consistency to proper storage, handling, distribution and traceability.

Demonstrate ability to produce safer and more effective medical devices.

Improve operation efficiency through continual improvement processes.