Our Promise to Quality
- Certifications -
As an organization, we are committed to upholding the highest standards of quality, safety, and ethical business practices. To this end, we comply with ISO 13485 and 21 CFR 820 regulations, which govern medical device manufacturing, quality management systems, and good manufacturing practices at home and abroad.
Furthermore, we are proud to hold a Human Rights Certificate, which demonstrates our commitment to respecting human rights and ensuring that our business practices align with internationally recognized human rights standards. This certification validates our dedication to social responsibility and ethical business practices.
In addition, we are committed to responsible sourcing and have implemented the Conflict Minerals Reporting Template to ensure that our products do not contain minerals that are sourced from conflict-affected areas.
By adhering to these standards and certifications, we aim to provide our customers with the highest quality products while also demonstrating our commitment to ethical business practices and corporate social responsibility.
- Facility & Cleanroom -
At our facility, we take great pride in providing sterile medical devices processed in a class 7 cleanroom. Our cleanroom meets the highest standards for cleanliness and sterility, ensuring that our products are safe for use in medical settings. Our facility adheres to rigorous protocols and procedures, and our highly trained staff ensure cleanliness and prevent contamination during the manufacturing process.
We understand the importance of maintaining a sterile environment and take every precaution necessary to ensure that our cleanroom meets the required standards. We regularly monitor and validate our cleanroom to ensure that it continues to meet these standards.
Our commitment to maintaining a sterile environment is an essential component of our quality management system, and we continuously strive to improve our processes to ensure that we maintain the highest standards of quality, safety, and reliability.
- Inspection -
We follow a Verification and Validation (V&V) process to ensure that our products are thoroughly tested and validated throughout the design and manufacturing process. This process includes testing and verification of all critical components and systems, as well as comprehensive testing of the final product to ensure that it meets all specifications and performance requirements.
In addition, we offer an optional 100% inspection process for our customers who require an extra level of assurance that their products meet their specific requirements. This inspection process involves inspecting every product that leaves our facility to ensure that it meets or exceeds the customer’s specifications.
By following our inspection criteria, V&V process, and offering an optional 100% inspection process, we are confident that we are delivering high-quality products that meet or exceed customer expectations. We are committed to continuously improving our processes to ensure that we maintain the highest standards of quality and customer satisfaction.
- Quality Audits -
We are committed to supporting our customers throughout their auditing process. Our team is available to provide assistance and facilitate communication with our suppliers, including translation services if necessary. We understand the importance of transparency and open communication during audits and are dedicated to ensuring our customers have access to all relevant information.
Our goal is to provide a seamless and stress-free auditing experience for our customers, ensuring they have the information they need to make informed decisions. We believe that an effective auditing process is essential to maintaining the highest standards of quality, and we are committed to supporting our customers throughout this process.
Our dedication to quality and customer service extends beyond the manufacturing process, and we take great pride in our ability to provide excellent customer support during the auditing process.