Quality Assurance & Regulatory Affairs

Our Promise to You:
At the core of our work is a simple promise: to deliver surgical instruments that you can trust when it
matters most. We don’t just meet industry standards; we aim to surpass them. With ISO 9001 and ISO
13485 certifications, we’ve designed every part of our process to ensure that our instruments are safe,
dependable, and built to last.
Materials That Matter:
We know that in surgery, even the smallest detail can make a big difference. That’s why we carefully
select only the highest-quality materials, like premium stainless steel, known for its strength and
resilience. Before we begin crafting your instruments, each material undergoes rigorous testing to
ensure it meets our high standards—because your trust matters to us.
Precision Is Our Priority:
For us, precision is more than just a goal; it’s a necessity. We use cutting-edge technology like CNC
machining and laser cutting to create instruments that are accurate and consistent, every single time. To
make sure you get exactly what you need, we regularly calibrate and validate our equipment.
Meticulous Inspections:
Before any instrument leaves our hands, it’s put through a detailed inspection process. We check every
dimension, test its functionality, and make sure the surface finish is flawless. For the instruments that
matter most, we even perform non-destructive testing (NDT) to ensure they’re as strong and reliable as
you need them to be.
Sterility You Can Rely On:
We understand the importance of sterilization in the surgical field. That’s why our instruments are
designed to be compatible with various sterilization methods, like autoclaving and ethylene oxide (EO)
sterilization.
Committed to Compliance:
Navigating the complex world of regulations can be challenging, but we’ve got it covered. We proudly
hold ISO 9001, ISO 13485, and CE Marking certifications, and our instruments comply fully with the
93/42/EEC Directive. We’re also FDA-approved, so you can trust our products to meet the highest safety
and quality standards, both in the U.S. and internationally.
Transparent Documentation:
We believe in being transparent with our clients. That’s why we provide comprehensive documentation
with every order, including Certificates of Conformity (COC) and material test reports. Our robust
traceability system ensures that every instrument can be traced back to its origin, so you know exactly
what you’re getting.
Always Ahead of the Game:
The regulatory landscape is always changing, and we make sure we’re always ahead of the curve. Our
Regulatory Affairs team stays up-to-date with the latest changes and industry trends, ensuring that our
products are always compliant. Whether its FDA 510(k) submissions or CE Marking, we’re here to
support you.
Ongoing Safety Commitment:
Our commitment to safety doesn’t end once our instruments are in your hands. We continuously
monitor their performance through our post-market surveillance system, gathering feedback to make
ongoing improvements. Your safety is our top priority, and we work hard to ensure our products remain
at the forefront of the industry.
Open to Audits:
We welcome audits from clients and regulatory bodies alike because we stand behind our work. Our
facility is regularly audited to ensure we maintain the highest standards, and our certifications are proof
of our commitment to quality and excellence.
Sustainability in Action:
We believe that quality isn’t just about the products we make; it’s also about how we make them. That’s
why we’re committed to sustainable practices, using eco-friendly materials and energy-efficient
processes whenever possible. We’re not just taking care of our clients—we’re taking care of our planet
too.
Constant Improvement:
For us, quality is a continuous journey. Our Quality Assurance and Regulatory Affairs teams are always
looking for ways to improve, whether it’s through new technologies, refined processes, or enhanced
products. Because when it comes to quality, there’s always room to grow.