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).
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.
The quality assurance tests are performed to ensure that every instrument being manufactured, perform its function during critical surgical procedures.
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.
Critical dimensions are measured with calipers, micrometers, or other specialty gauges and compared to technical drawings to ensure pattern consistency.
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.
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.
Surgical, Dental, and Beauty Instruments