Medical and surgical equipment - Import export

MUSTANOGLU PROFESSIONAL MEDICAL EQUIPMENTS SALON DEVICESREGIONAL REVIEW REGIONAL THINNING DIODE LASER EMS SLIM EMS HIEMT 7D HIFU 4D HIFU HYDRAPRO Q-SWITCH PLASMA G5 LENF DRAINAGE INBODY PDT SKIN ANALYSIS ROLL SLIM

The new European Commission’s guidance on persons responsible for regulatory compliance (PRRC) explains that manufacturers, Authorized Representatives and micro and small manufacturers must designate at least one staff member responsible for ensuring compliance to the MDR and/or IVDR as appropriate according to Article 15 of the Regulation. PRRC qualifications are specific for each of these three operators. This does not mean that you have to hire PRRC as employee rather you can avail our PRRC service to overcome the regualtory needs of your company and medical devices – with a consultant managing the system on a few days per month basis. We would be more than happy to discuss this option with you, helping you to find a consultant with the necessary qualifications to perform this service effectively. If you would like to know more about this service, then please contact us.

Our experienced team has for years done documentation for companies who are manufacturers of medical devices /surgical instruments. We provide Quality-Management-Systems for meeting legal and normative requirements. For manufacturers of medical devices / surgical instruments class I (including Is, Im, and new for MDR class Ir), IIa, and IIb we offer the following services:
 Implementation DIN EN ISO 13485 and the EU-Regulation 2017/745 MDR and 21 CFR 820 QSR Creating QM-Systems with procedural instructions and work instructions Technical Documentation Clinical evaluation Risk Management / Risk Analysis Essential Safety and Performance Requirements Validation of processes UDI-labeling Consulting for Regulatory Affairs Internal audits and external supplier audits Accompaniment and support with inspections by authorities and Audits by notified bodies Communication with authorities

This innovative solution enables an immersive remote connection experience with operating rooms to improve the quality of care for technicians and surgeons. Main Features: VIDEOCONFERENCE Allows communication with technicians or colleagues who are required during the intervention. REMOTE CONTROL Allows remote control of medical equipment in the operating room to make support more efficient. It can be several equipments simultaneously and multi-brand. VIDEO CAPTURE Connect as many capturers as you wish and share the image of the operating room screens with other colleagues. Our software will allow you to generate pre-formatted layouts with the images. CAMERA CONTROL A PTZ camera is included in the operating room, which can be remotely controlled through the application, in order to explore the environment in detail, rotating the camera and zooming in where needed.

Let virtual and mixed reality transform your preoperative training in surgical planning and skills. PRE-OPERATIONAL PLANNING: Get the complete image before entering the operating room. SURGICAL SKILLS TRAINING: Enhanced learning through virtual and mixed reality.

Carries out spectrophotometric analysis with the registration of arterial temperatures infrared radiation. Cannot be used without an interface block. The module can: • noninvasively obtain 85 biochemical parameters of peripheral and hemodynamic blood composition; • obtain hemodynamic parameters; • obtain various information about the oxygen transportation in the blood; • analyze the cardiovascular system activity; • study affiliation with the hematopoietic, immune and enzyme systems of the body.

This product allows to control, plug and play mode, any equipment into a surgery room. Just connect our receptor to the USB port and program your macros (mouse and keyboard movements). Assign a voice command to them and each you say it, the macro will be executed in the device.

Body composition measurement by means of the LineBIA method is based on assessing the distribution of water volumes in the human body and on tissue ability to conduct electricity. Cannot be used without an interface block. The module can: • determine the quantitative content of fluid in the body, body mass index, standard metabolism; • determine the active cell mass, bone mass, fat mass; • obtain unbiased data on the human body quantitative composition; • get linear control and timely correction of nutrition programs in clinical practice and sports medicine; • an unbiased assessment of physical conditioning and nutrition; • analyze the water-salt metabolism; • analyze the state of water-salt metabolism during the period of adaptive changes in the human body, under changing weather conditions (mountain climate, hot climate, or dry climate).