medical-device-directive Downloads
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Medical Oxygen(Container Solution)Highest level of international approvalOxymat Medical systems are designed and manufactured according to : • MDD(93/42/EEC) Medical Devices Directive• US Pharmacopoeia• European Pharmacopoeia• ISO 10083Oxymat has long experience in design, engineering and delivery of Oxygen ...
Some 30,000 professionals have gained from more than 500 training courses we have conducted till nowBy John E Lincoln, Consultant, Medical device and Regulatory AffairsJohn E. LincolnConsultant, Medical device and Regulatory Affairs 2-day In-person Seminar 2013About Speaker:John E. ...
Highest level of international approvalOxymat Medical systems are designed and manufactured according to : • MDD(63/42EEC) Medical Devices Directive• US Pharmacopoeia• European Pharmacopoeia• ISO 10083Oxymat has long experience in design, engineering and delivery of hundreds of Oxygen systems all over the world, in accordance ...
Complete with pillow and carrying bag, Allows immobilisation of trunk, head and spine and extraction of patients from hard-to-access areas, Wrap-around and flexible design, Equipped with coloured ribbon and quick release/hook buckles, Equipped with shaped wooden splints that give rigidity to the device, Made of washable blue fabric, Radiolucent, Class I medical device in accordance with ...
Tristel Solo for Ultrasound disinfectant wipes are designed specifically for the simple and effective disinfection of skin surface probes and ultrasound station monitors, keyboards, probe holders and cables. Tristel Solo for Ultrasound disinfectant wipes are based on a Quaternary Ammonium Compound (QAC) in the form of didecyl dimethyl ammonium chloride. To aid cleaning and soil removal, the ...
These sterilizers are designed for all Healthcare applications including surgery, central sterile supply and clinical laboratories. PRIMUS sterilizers are designed and manufactured in the USA according to Quality Management Systems which are in compliance with ISO 9001:2008, ISO 13485:2003, CMDCAS and FDA's Good Manufacturing Practice (GMP) for Medical Devices: General regulation (21CFR Part ...
DAMALENE suture is synthetic non-absorbable sterile surgical suture, composed of isotactic crystalline stereoisomer of Polypropylene, a synthetic linar polyolefin. It is Monofilament dyed sutures. DAMALENE suture has high in vivo tensile strength and has the further advantages of being remarkably smooth & easy to handle resulting in minimal tissue trauma. DAMALENE suture complies with the ...
DAMALON suture is synthetic non-absorbable sterile surgical suture. It is composed of Polyamide polymers. It is Monofilament dyed sutures. DAMALON suture has high in vivo tensile strength, does not support bacterial growth and has the further advantages of being remarkably smooth & easy to handle. DAMALON suture complies with the requirements of the United States pharmacopoeia U.S.P. and ...
NOSOSEPT 100 is a broad spectrum antimicrobial disinfectant spray specially formulated for the rapid cleaning and disinfection of surfaces of medical devices. Active in 30 seconds, its use after each session prevents cross-contamination between patients. It is recommended for surfaces of medical devices in direct contact with patients and medical personnel such as trolleys, benches, ...
ByMedalkan
TÜV Rheinland Product Safety GmbH as a “Notified Body” for all medical devices, including active implantable medical devices and in-vitro diagnostic medical devices, TÜV is the partner you are looking for.TÜV can offer certification for products and quality management systems for ...
We are proud that today customers in more than 70 countries enjoy the outstanding quality of our medical test strips.In addition, many pharmaceutical companies rely on MACHEREY-NAGEL. pH test strips manufactured by MN are used to monitor the dosing of different medications. We have gained the IVD application with CE certi?cation according to the IVD ...
With the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) becoming applicable in May 2022, the European Bioanalysis Forum, as many others, is looking at the impact of this regulation on (bio)pharmaceutical drug research and development. Already, we observe a growing concern of the industry on potential scope creep of the IVDR into early clinical studies for assets where it is believed the ...
Tuttnauer also sells sterilant, and biological indicators & chemical indicators.Clean Technology• Non-toxic sterilizing agent• Minimal utility requirements – low electricity consumption, no water consumption• The sterilization process results in water and oxygen by-productsVertical Sliding DoorAutomatic Vertical Sliding Door with built-in foot operated device for hands-free door ...
This guarantees that if a problem should occur, an autoclave failure will be prevented. • A safety device prevents the operator from opening the door when chamber is pressurized • Steam is not allowed into the chamber when the door is open• A cycle cannot start if the door is open or not properly locked • The door cannot unlock until chamber pressure reaches room pressure• ...
Oxymat operates a QA system in accordance with international standards• ISO 9001 (Quality Management Systems) • ISO 13485 (Quality Management Systems – Medical Devices)• ISO 14001 (Environmental Management Systems) certified by Apragaz. ...