Safety and quality are non-negotiable in the medical devices industry. With the stringent regulatory requirements and specialized medical standard certifications, PROMED stresses the high quality standards, and their performance for our customers and partners.
In an ever-changing environment of technology and culture, PROMED stays ahead by constantly changing and adapting ourselves. We maintain an open mind to grow, understand the needs and create competitive quality products.
We place great importance on product quality and durability from development stage. We perform comprehensive quality and functionality checks of all products and production cycles. Doing all these, we make sure our products meet all relevant international standards and regulations.
OUR QUALITY PRODUCTS
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WE ARE PROMED
PROMED represents a dedicated team of Medical Professionals, including experts in Research & Development, Product Marketing, Quality & Regulatory, Production and Corporate Management. We pursue and maintain the goal of excellence.
PROMED is your trustworthy and reliable partner in the high demanding medical market. Today, PROMED continues to fulfil market demand with innovative products in a reliable and cost-effective manner.
WHAT SETS US APART
WHY CHOOSE PROMED
Quality first is everything we do. As a legal manufacturer of sterile medical devices we are required to comply with the requirements of the FDA’s 21CFR 820, as well as ISO 13485. These specialized medical quality standards are the foundation of our quality management system and services. In addition, these stringent regulatory requirements ensure defect prevention, continuous improvement, reduction of waste and variation in the supply chain, and finally help us to deliver state-of-the-art products that meet or exceed the requirements.
PROMED owes its success to the strong leadership and competence of the senior management team. With decades of broad experiences in medical product development and manufacturing cycles, the lead management team has assured continual success for the past and the future of PROMED. Meanwhile, we value our respectful and supportive teammates. We give our teammates clear direction with trust while encouraging their balanced lifestyle and individual development.
Manufacture of sterile medical devices requires careful planning and allocation of resources in order to safeguard excellent performance. Meanwhile, it requires flexible and active collaboration throughout the organization so that product characteristics and manufacture competencies are in best combination without sacrificing product quality. The PROMED team truly partners and contributes his expertise to achieve our success in global medical market.
We think sustainably! We are committed to giving back to the society and environment. Long-term engagement is one of our strategic priorities. Non-hazardous materials complying REACH & RoHS directives are utilized in PROMED products. Meanwhile, we request similar support and cooperation from the entire supply chain from materials, critical components, assemblies and services providers.
ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes, is an internationally agreed standard. We can proudly and safely state that PROMED products are built with quality and transparency in mind to provide products that meet or exceed the needs and expectations of our customers, and always complying with the specifications and regulations.
The Medical Device Single Audit Program (MDSAP) is a harmonized approach to auditing and monitoring the quality management systems of medical device manufacturers on an international scale that will cover and their respective regulatory requirements. The current program participants include: USA, Canada, Australia, Japan and Brazil.
THE MEDICAL DEVICES DIRECTIVE, CE MARKING FOR EUROPE
Manufacturers of Class I (sterile/measuring), IIa, IIb and III devices must obtain certification against the CE marking directive, 93/42/EEC. PROMED has acquired this certification and our products are eligible to be marketed in Europe.
This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. PROMED products are cleared under FDA 510(k) requirement and are also qualified and marketable in the United States.