Certification

We are a medical device manufacturing company. We are equipped to manufacture medical devices from research & development to production. Our quality management systems are registered to ISO 9001: 2015 and ISO 13485 : 2016, with white room manufacturing available.

We understand the unique requirements of the medical device industry from speciality lot sizes (development samples, scale-up) to regulatory compliance and qualification. We look forward to supporting your medical needs.

Our mission is to ensure patient safety whilst supporting timely market access to global medical device technology. We strive to set the global standard in thorough, responsive, robust conformity assessments, evaluations and certifications that are recognized and trusted worldwide.

We also have CE certification on many products according to the latest regulations.