Certification
Our Commitment to Quality – ISO 13485 Certified
At Regal International, we take great pride in our unique ability to combine functionality and beauty in every product we create, especially for the medical industry. Our products are not only engineered to perform at the highest level in demanding medical environments, but they are also crafted with an aesthetic vision in mind, ensuring that they stand out for their sophisticated design, user-friendly interface, and exceptional durability. We understand the importance of medical instruments not only being effective and reliable but also visually appealing, which is why we go the extra mile to ensure both form and function are seamlessly integrated into each item we produce.
Our commitment to quality goes beyond the surface, as we hold ourselves to the highest manufacturing standards. Regal International guarantees the performance of our instruments for life, standing by the craftsmanship of every item we produce. We offer a lifetime guarantee that ensures our customers receive a product that is free from any manufacturing defects, providing complete peace of mind and long-term value. This means that our clients can trust in the durability and reliability of our products, knowing that any potential issue stemming from manufacturing will be addressed without hesitation.
Our dedication to excellence extends throughout every aspect of our operations, and this is further validated by our rigorous quality management system. Regal International’s quality management system has been certified by the esteemed DCS CERT Certification body of Dynamex Certification Services, based in Italy. This certification demonstrates our adherence to the highest international standards for quality, ensuring that all of our processes—from production to customer service—are consistently monitored, evaluated, and improved. By upholding these strict quality controls, we ensure that every product we deliver meets or exceeds the expectations of our customers, and we continue to strive for innovation and improvement in every product we create.
With Regal International, you are not just receiving top-tier medical instruments; you are gaining a trusted partner dedicated to providing you with both cutting-edge functionality and the best craftsmanship the industry has to offer. We are committed to delivering products that perform flawlessly, support the highest standards of healthcare, and contribute to the success of medical professionals and institutions worldwide.
Certifications and Compliance
Regal International adheres to the strictest international standards, holding the following certifications:
- Good Manufacturing Practices
- Registration Confirmation Letter CGMP
- ISO Certificate 9001
- ISO 13485
- EC Certificate
- EC Class 2
- EC REP 2022
- CH REP
- CMC REG
- UKCA
State-of-the-Art Manufacturing
Regal International's advanced manufacturing process, combined with its cutting-edge quality laboratory, has undergone rigorous evaluations and has successfully met all the necessary requirements to be officially certified as compliant with ISO 13485 standards, which are specifically set for the medical device industry. This certification assures that the company consistently adheres to the highest standards of quality and safety in the design, production, and testing of its medical devices.