Quality Control
Prowa Medical Instruments | Quality Control
Commitment to Quality
Prowa Medical Instruments is committed to supplying its customers with the highest quality products and services. The company encourages the opportunities where learning and improvement enable talented people to realize their full potential to create an environment where a constant flow of great ideas. Prowa Medical Instruments strives to be better than yesterday. The company truly believes in the finest quality manufacturing, exceeding customer’s expectations and to promote quality culture to improve employee development .
Prowa Medical Instruments has achieved and maintained:
- The European Authorized Representative (EC REP) Certificate
- The EUDAMED SRN under EU Medical Device Regulation (EU MDR 2017/745)
- The QMS compliant with EU Medical Device Directive (EU MDD 93/42/EEC)
- The QMS according to cGMP by U.S. Food and Drug Administration (U.S. FDA)
- The QMS according to the ISO 9001 and ISO 13485 standards
- The manufacturing factory according to the ISO 14001 and ISO 45001 standards
All the instruments manufactured uses AISI grade 304 and grade 410/420 steel that comply with substantiated quality standards that we hold, ISO 9001, ISO 13485, CE Mark Compliance, and are FDA Approved. Furthermore, our company adheres strictly to the international quality standards, and to build the customers’ trust we hold the following quality management certifications as well: ISO 7151, ISO 7153-1, ISO 11135, ISO 13402, ISO 17664, ISO 17664-1, ISO 21850-1, ISO 14971, ISO 15223-1, ISO 20417, ISO 11607-1, ASTM A380-06, ASTM F899-20, and REACH Regulation (EU).
Capability
A personalized approach, with production at scale. Through a combination of internal product development and targeted, strategic acquisitions, Prowa Medical Instruments has expanded its portfolio to offer a unique mix of products. The company offers standard and custom solutions for individuals and companies.
Critical Dimensions
The quality assurance tests are performed to ensure that every instrument being manufactured, perform its function during critical surgical procedures.
Surface Inspection
All instruments are visualized for defects in material and surface finish. They must have a flawless satin finish and be free of excess lubricants and foreign substance.
Dimensions Verification
Critical dimensions are measured with calipers, micrometers, or other specialty gauges and compared to technical drawings to ensure pattern consistency.
Function Tests
In addition to general inspections, function tests are used to verify instrument quality.
Cutting tests are performed on testing material. Scissors must not snag or bind when cutting appropriate layers of material. The heavier the scissors, the more layers of material they must cut. Blades must close smoothly without hesitation. Visual inspection is performed for burrs, especially on the cutting edge. Screw lock must be secure and slight amount of hinge play should exist when opened.
Ratchets are checked for proper holding action. Tips are verified as either sharp, blunt or semi-sharp. Ratchet mechanisms must close smoothly. Holding power is tested to make sure ratchet remain engaged during use. Ratchet teeth must align properly.
Closed jaws are checked against a light source to ensure that no substantial amount of light passes through. Jaws are clamped on plastic testing material. The impression should be clean and consistent. Teeth must mesh together closely . Jaws must be properly aligned. Ratchets must engage crisply and smoothly. While engaged at the first ratchet tooth, instruments should not open when tapped lightly against the edge of a table.
Cutting tests are performed with the appropriate test material. Forceps must cut cleanly with the front half of the jaws. Tips must close properly from the top to the middle of the jaws.
Jaws must close tightly so that no light shines through the front 2/3 of closed jaws tested against a light source. Must hold suture material, and pass similar tests as outlined under forceps.
Cutting tests are performed according to the recommended maximum capacity of each instrument.
To consolidate our position in medical instruments manufacturing industry, the company is committed to the continuous improvement and development of employees, products, technology and processes. All of the workflow and methodology is embedded with ERP and SAP solutions for quality and time tracking.
Our workforce is trained to perform every step of production in such a manner that guarantees perfect results with complete traceability. Constant checks during manufacturing and at the end of a production process also ensures a long service cycle. The QA team of Prowa Medical Instruments regularly updates its documentation & policies to make sure that the company comply with the latest international regulations.