medical-device-regulations Downloads
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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 ...
Through our trainings, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Our services benef i t the Medical Devices, ...
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
Through our trainings, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Our services benef i t the Medical Devices, ...
It covers fundamental GMP (Good Manufacturing Practice) principles, which normally apply during the manufacture of medical devices.CMDCAS – Canadian Medical Device Conformity Assessment SystemCompanies that manufacture and/or sell medical devices in Canada must conform to CMDCAS, the purpose of Essential ...
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 systems all over the ...
Some 30,000 professionals have gained from more than 500 training courses we have conducted till now By: Consultant, Medical device and Regulatory affairs, John E Lincoln, Verification vs. ...
Through our trainings, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.Our services benef i t the Medical Devices, ...
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 ...
