Medipac’s Full Quality Assurance System, including the design, manufacture and final inspection of products, is in accordance with the national and international standards of quality and complies with the essential requirements of the Directive for Medical Devices 93/42/EEC.
Annual inspections by the notified body EKAPTY (National Evaluation Center of Quality and Technology in Health), ensure the continued compliance of the applied operations with the requirements of the aforementioned Directive and Standards.
In addition, we are in close cooperation with NAMSA, an internationally recognized medical research organization carrying out both biological risk assessment and clinical evaluation report studies.
All production and control activities are monitored closely by highly trained personnel, thus ensuring the desired characteristics of the end products, and fulfilling our customers’ demands.
We are devoted to delivering sutures that adhere to high quality standards, and we are focused on superior needle and thread strength, and exceptional needle-thread attachment. Our products achieve a tensile strength of up to 150N, 3 times above the minimum requirements of the European Pharmacopoeia.
Who we are
Profimed/PTFE Sutures
We were among the first manufacturers to produce PTFE sutures, in 2011. These are sterile, non-absorbable, monofilament surgical sutures made from polytetrafluoroethylene (PTFE) polymer, ideal for use in all types of surgical procedures.