Quality Control
Our Commitment to Quality at Sinus Instruments
At Sinus Instruments, our mission is to deliver exceptional quality products and services to customers worldwide. We foster a culture of continuous learning and innovation—encouraging our team to grow, contribute new ideas, and strive for excellence every day. Our goal is simple: to be better than yesterday in everything we do.
We are committed to precision manufacturing, exceeding client expectations, and cultivating a quality-driven environment that empowers both our people and our products.
Our Global Certifications & Standards
Sinus Instruments is proud to meet and maintain internationally recognized quality and regulatory standards, including:
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✅ European Authorized Representative (EC REP) Certification
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✅ EUDAMED SRN Registration under EU MDR (2017/745)
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✅ Quality Management System (QMS) compliant with EU MDD (93/42/EEC)
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✅ QMS in line with cGMP – U.S. FDA (Food and Drug Administration)
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✅ Certified to ISO 9001 and ISO 13485 Standards
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✅ Manufacturing Facility Compliant with ISO 14001 & ISO 45001 Standards
These certifications reflect our dedication to compliance, safety, environmental responsibility, and workplace health—ensuring our instruments consistently meet the highest global 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).
Our Capabilities
At Sinus Instruments, we combine personalized service with the ability to scale. With a strong foundation in in-house product development and selective strategic partnerships, we’ve built a versatile portfolio that includes both standard and customized solutions—designed to meet the needs of individual professionals and global healthcare companies alike.
Critical Dimensions
Each instrument undergoes rigorous quality assurance testing to verify its performance in critical surgical procedures, ensuring absolute reliability in the operating room.
Surface Inspection
Every instrument is carefully examined for material integrity and surface perfection. We ensure a flawless satin finish, free from any residual lubricants, scratches, or foreign particles.
Dimensions Verification
Key measurements are checked using calipers, micrometers, and specialized gauges, then matched against technical design drawings to maintain strict consistency and pattern accuracy.
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.
