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YOUR BUSINESS PARTNER THROUGH THE ENTIRE LIFE CYCLE OF YOUR MEDICAL DEVICE

We believe in total quality assuarance

At SMJConsulting we emphasize and ensure that all our client´s employees and suppliers are responsible for their activities; design requirements are established and met; process requirements are established and met; all production activities are controlled; finished product specifications are met; and feedback results in appropriate corrections. Product design assurance is a QA system which assures that customer needs are determined, and that product design requirements are established and met. 

We believe, an ideal QA system is composed of an organization that executes a QA program according to documented policy and specifications in order to achieve stated objectives. All activities and product quality are monitored; and any deviations from device and process specifications and company policies are fed back into the system where the deviations are corrected. Likewise, complaint and service information are processed and fed back for appropriate corrections.

It is our understanding that quality assurance (QA) activities do not simply consist of inspection and testing spot solutions or "fire-fighting,” no matter what the product is or how small the manufacturer.

These areas include product development, design verification and validation, component and/or supplier selection, documentation, development of labeling, design transfer, process development and validation, pilot production, routine manufacturing, test/inspection, device history record evaluation, distribution, service or repair, and complaints.

Management and employees should have the correct attitude if their quality system program is to be effective. After a quality system is in place and checked, it should not be allowed to stagnate, it should continue to be dynamic. The system remains dynamic through continuous feedback, "big-picture" monitoring by system audits, management review, and corrective and preventive action. 

The result is an organization that is operating in a known state-of-control for the device design, process design, manufacturing processes, and records. A properly functioning quality system results in increased safety and effectiveness of the device, reduced liability exposure, reduced regulatory exposure, increased customer satisfaction, less scrap, lower costs, much less confusion, higher employee morale, and, as a result, higher profits.

the firm

SMJ Consulting

Brådebæksvej 33 L

DK-2970 Hørsholm

CVR: 32749542

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