Quality through design and process innovation

Swenggco Medical is totally committed to today’s quality requirements. We comply to and are registered with ISO 13485:2016, EU Medical Device Regulation (MDR) 2017/745 CE and USA FDA QSR (cGMP).

We operate a quality management system that addresses the compliance with international & local applicable standards of quality and assurance of complete customer satisfaction through continuous improvement.

Only the highest quality raw materials, machinery and workmanship is used in our manufacturing processes that complies with international standards.

Quality through design and process innovation

Swenggco Medical is totally committed to today’s quality requirements. We comply to and are registered with ISO 13485:2016, EU Medical Device Regulation (MDR) 2017/745 CE and USA FDA QSR (cGMP).

We operate a quality management system that addresses the compliance with international & local applicable standards of quality and assurance of complete customer satisfaction through continuous improvement.

Only the highest quality raw materials, machinery and workmanship is used in our manufacturing processes that complies with international standards.

We prioritize inspection and quality control to ensure that every surgical instrument we produce meets the highest standards of safety, precision, and reliability. Our dedicated quality control team conducts rigorous testing at every stage of the manufacturing process, from raw material inspection to final product evaluation. We utilize advanced measurement tools and techniques to verify the accuracy, durability, and functionality of each instrument, ensuring it performs flawlessly in the most demanding surgical environments. By adhering to strict industry regulations and quality standards, we guarantee that every instrument that leaves our facility is of the highest quality, providing healthcare professionals with the confidence they need in their tools.

Certificates

ISO 13485 Certificate (2025)
ISO 13485:2016 Certificate
CE Certificate - Swengg Co
CE MDR Compliance Certificate
FDA Certificate
US FDA Registration Certificate