WE ARE
CERTIFIED
Safety and quality are non-negotiable in the medical device industry. With stringent regulatory requirements and specialized medical standards, PROMED places strong emphasis on maintaining high quality standards and reliable product performance for our customers and partners.
WE ARE
INNOVATIVE
In an ever-changing environment of technology and market needs, PROMED continues to evolve and adapt. We maintain an open mind, listen to our customers and continuously improve our products. As a result, we are able to develop competitive and reliable medical device solutions.
WE MANUFACTURE
QUALITY PRODUCTS
We focus on product quality and durability from the development stage onward. Our team performs quality and functional checks throughout production. These controls help ensure that our products meet applicable specifications, standards and regulatory requirements.
General Surgery
• Disposable & Reusable Electrosurgical Pencil
• Disposable Electrode, High Insulation
• Disposable LLETZ / LEEP Electrode
• Reusable Bipolar Forceps
• Disposable Ground Pad and Cable
• Disposable Smoke Evacuation Pen
Precision Surgery
HOT: Aesthetic, Plastic & Cosmetic Surgery
– Perfect for Eyelid lift Brow lift Face lift Rhinoplasty
• Microfin Compact Electrosurgical Pencil
• Microfin Bendable Gold Electrode
• Microfin Ultra Sharp Microdissection Needle
Less bleeding, less scar, less smoke, shorter recovery period
Arthroscopy
• Disposable Arthroscopic Electrode
Laparoscopy
• Disposable Laparoscopic Electrode
• Disposable Laparoscopic Instrument
• Disposable Suction Irrigator
Wound Closure
• Disposable Skin Stapler
• Disposable Staple Remover
Personal Protective Equipment
• Surgical Mask
• Surgical Isolation Gown
PROMED brings together specialists in R&D, product marketing, quality and regulatory affairs, manufacturing and corporate management. Our teams work together to develop reliable medical devices and support customers in international markets.
PROMED aims to be a reliable partner in the highly regulated medical-device market. We continue to develop practical, innovative and cost-effective products that respond to changing customer needs.
ISO 13485 is an internationally recognized quality management standard for the medical device industry. It provides a framework for maintaining consistent quality, meeting regulatory requirements and supporting continuous improvement.
PROMED applies these quality principles to help ensure that our products and services meet applicable specifications and customer expectations.
The Medical Device Single Audit Program (MDSAP) provides a harmonized approach to auditing the quality management systems of medical device manufacturers.
The program supports regulatory oversight across participating markets, including the United States, 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.