Asian medical device manufacturers can turn to Niutec for European market entry
- Niutec is renowned for biocompatibility testing, chemical characterisation and cleanliness testing of medical devices, and its turnaround time is unmatched
Country Business Reports interviews and articles by Discovery Reports
A changing regulatory landscape poses challenges to medical device manufacturers outside of Europe, for whom the long-standing expertise of leading Swiss private chemical research and testing laboratory Niutec can support market penetration in Switzerland and throughout Europe.
“Though we are a small company, we can support clients very well because we know the market and we know the products,” says Agi Mosberger, managing director.
Niutec’s expertise dates to 1968 when Switzerland’s Sulzer Group started material technology activities. Following a management buyout in 2000, the company directed its growing team of experts, laboratory technicians and specialists to focus on chemical analysis and development in the fields of industry, environment and medical technology. Its customer-centric approach has paved the way for benchmark innovative products that are compliant with standards for quality management systems, and testing and calibration laboratories.
“We have developed a testing method, which is very important for medical device testing today,” says Daniel Zurbrügg, chief technology officer.
Niutec is renowned for biocompatibility testing, chemical characterisation and cleanliness testing of medical devices. Its turnaround time for biocompatibility testing is unmatched at shorter than two months, vis-à-vis the prevalent six months among competitors globally. It can respond quickly and efficiently to quality managers, researchers, engineers or accident experts who need reliable data to ensure production efficiency and product acceptance in new markets.
Apart from high-performance laboratory analyses, Niutec also provides individual training for the professional development of clients’ employees. Efficiency in producing top-quality products is critical amid stringent patient safety regulations worldwide for medical devices such as implants, instruments, apparatus and various accessories.
Aiming for expansion in Asia, Niutec welcomes partnerships with well-established regional distribution and medical device companies that have a strong local regulatory know-how and an extensive footprint across China and Southeast Asia.
“Collaboration is quite important, and we look forward to new partnerships in Asia to support the market entry of medical devices in Europe,” Zurbrügg says.
