Quality
SURGIMEDIC Quality Management System has been documented and maintained as per EN ISO 13485:2016 standard. The organization has implemented and maintained all requirement, procedure, activity or arrangement as per standard and regulatory requirements.
For each quality management system process, SURGIMEDIC:
- Determine criteria and control methods needed to ensure that both operation and control of these processes are effective.
- Ensure the availability of resources and information necessary to support the operation and monitoring of these processes.
- Implement actions necessary to achieve planned results & maintain the effectiveness of these processes.
- Monitor and measure as appropriate & analyze these processes
- Establish & maintain records needed to demonstrate conformance to the MDQMS and compliance with applicable regulatory requirements.
Product Realization
SURGIMEDIC has planned and developed the processes needed for product realization. Planning of product realization is consistent with the requirements of the other processes of the quality management system.
One or more processes for risk management in the product realization are documented & the records of the risk management activities as per the standard EN ISO 14971:2012 are maintained.
In planning product realization, the following are determined:
- Quality objectives and requirements for the product.
- The need to establish processes and documents& to provide resources specific to the product, including infrastructure and work environment.
- The verification, validation, monitoring, measurement, inspection and test, handling, storage distribution and traceability activities along with the acceptance criteria for the product acceptance are defined.
- Records showing the evidence that the realization processes and resulting product meet requirements.
- The output of product realization plan is documented in a form suitable for the organization’s method of operations.
A strict Quality Control protocol is followed at each stage of manufacture. The tests include:
Sharpness testing
which is done on a specially designed digital sharpness comparator where the force required for the needle point to penetrate a diaphragm of polyurethane standardized synthetic material (whose characteristics closely mimic the human skin) is measured.
Stiffness
of the needles is also evaluated with a special digital tester which enables the force-vs.-displacement of the needle to be determined, and which also determines whether the needle re-gains its original shape without any permanent set.
Corrosion Resistance
is tested in accordance with IS 7135-1998 and other international standards
Ductility
is evaluated by bending the needle body through a sharp 90 degree angle, which it should withstand without cracking.
Hardness measurement
is done on a micro-Vickers hardness tester, which measures the dimension of the indentation made with a diamond pyramidal indentor which is applied to the polished surface of the needle with a pre-determined force.
Attaching strength
the attaching strength measured with a digital tensilometer to ensure that pull strength conforms to USP standards.