Navigation Menu
The EU Medical Devices Regulation EU MDR and EU in vitro Diagnostic Medical Devices Regulation EU IVDR The EU MDR and EU IVDR will fully apply in EU Member States from 26 May 2021 and 26 May
Single use plastic products SUPs are used once or for a short period of time before being thrown away The impacts of this plastic waste on the environment and our health are global and can be drastic Single use plastic products are more likely to end up in our seas than reusable options The 10 most commonly found single use plastic items
Announcement More flexibility and convenience of flow measurement in upstream and downstream applications Combining its flexible use of analog and digital interface with measuring options for up to two flow channels per device and a sleek and easy to integrate design for the control cabinet our new BioProTT Flow MCP a series provides a reliable flexible and convenient flow measurement
The UDI or Unique Identification Number Europe as there is also one in the USA is one of the new things that come with the new EU MDR 2017/745 and IVDR 2017/746 This element will be key for the traceability of devices in Europe Origin To be specific the concept of UDI did appear on the IMDRF guidance issued in 2013 This defined the basis of this new technology
Get product career investor and contact information about Ambu a medical device company that helps healthcare professionals save lives
Respected Global Leader in Flow Cytometry and Single Cell Proteomics with an Ability for up to 40 Parameter Analysis Quality driven Services that Accelerate our Client s Clinical Trials Pre Clinical Toxicity and Discovery Initiatives Over a Decade of Partnering with Top Pharma and Biotech Companies with >90 Repeat Business
Medical Devices Water Treatment Flowmeters Disposable Single Use Series Our turbine flowmeters measure flow using infrared reflections a more detailed explanation can be seen in the video Automatic calibration system for disposable single use solutions Shop here All products Contact
The COVID 19 lateral flow rapid antibody test developed by Abingdon Health the medical device manufacturer leading the UK Rapid Test Consortium UK RTC has received its CE mark This means it is approved for professional use in the UK and EU This milestone means the rapid antibody test for the detection of IgG neutralising antibodies to
Featured Product Allegro Plastic Totes Pall s collapsible plastic Allegro totes enable easy implementation of 50 L 100 L 200 L and 500 L single use systems around each unit operation while reducing manufacturing footprint The Allegro plastic tote has been specifically engineered in order to provide maximum flexibility in the processing
Cook Medical is a family owned medical device company that works with physicians to develop devices that are less invasive for patients Many of our Cook Medical sites including this one and our Instructions for Use IFU Finder are scheduled for server maintenance on Saturday 14 August 2021 from about 2 to 10 pm EST GMT 5
The first exchanges took place between Estonia and Finland in January 2019 Twenty two EU countries are expected to exchange such health information by 2021 This Recommendation builds on and contributes to the further development of eHDSI by facilitating the EU wide interoperability and exchange of comprehensive electronic health records
MedTech Europe guidance for assigning Basic UDI DI 2 June 2020 v1 1 1 The European database on medical devices to be set up under Regulation EU 2017/745 and Regulation EU 2017/746 Please use the flow chart in conjunction with the explanations on the following page
Breaking the Size Barrier in CO 2 Sensing The SCD4x series is Sensirion s next generation miniature CO 2 sensor that offers the smallest size combined with an unmatched price to performance ratio The series consists of the SCD40 and SCD41 CO 2 sensors Both sensors are built on the photoacoustic sensing principle and Sensirion s patented PASens and CMOSens Technology to enable
SupportContact Us Respiratory Manufacturer Mercury Medical Product Accessories Color coded manometers PEEP valves anatomical face and round silicone masks and filters Product Accessories such as the IGuard and nose clip are just a few of the items we have available to our customers Color coded manometers PEEP valves anatomical face and round silicone masks as well as
Single use systems have become an important tool in the development and scale up of biotechnology processes Single use systems save space increase flexibility in scale and space planning and to a large extent eliminate cleaning costs in development and change over However single use systems
Blood and Fluid Warming System The 3M Ranger Blood and Fluid Warming System with SmartHeat Technology adapts to virtually any fluid warming needs from KVO keep vein open to in excess of 30 litres per hour A variety of disposable sets that meet your fluid warming needs are available including paediatric standard and high flow sets
2 days ago MR Conditional with the use of 1 5 Tesla and 3 0 Tesla static magnetic field scanners The ventilator can remain close to the patient even during MRI scans Integrated TeslaSpy magnetic field navigator Adult pediatric and neonatal ventilation Up to 9 hours of battery operating time
SONOTEC is a leading specialist in ultrasonic measurement technology solutions With more than 180 employees the technology company based in Halle Saale Germany develops and manufactures customer specific ultrasonic transducers sensors testing equipment and measuring technology solutions for Non Invasive Fluid Monitoring Preventive Maintenance and Non Destructive
GUIDANCE medtecheurope Page 1 of 16 Use of Symbols to Indicate Compliance with the MDR December 2019 Version 2 0 replaces original version of May 2019 The Medical Devices Regulation 2017/745/EU MDR has new requirements that ask for various kinds of information to be indicated on the label of medical devices
EU Individual Case Safety Report ICSR Implementation Guide EMA/51938/2013 Page 5/112 I A Introduction Regulation EC No 726/2004 Directive 2001/83/EC as amended Directive 2001/20/EC and
Medical gloves in EU/EEA countries should comply with requirements defined in the Council Directive 93/42/EEC 6 concerning medical devices and the Regulation EU 2016/425 7 relating to personal protective equipment The European Standard EN 455 on medical gloves for single use specifies requirements for the quality of medical gloves
Figure 5 1 Examples of impacts of mismanaged single use plastics 64 Figure 5 2 Impact of national bans and levies on plastic bag usage based on more than 60 countries experience 65 Figure 5 3 Roadmap for policymakers 10 steps to consider when introducing bans or levies on single use plastics 67 List of Boxes Box 1
Purple Surgical are a long established well respected British Manufacturer of medical devices and instrumentation Find out more Purple Surgical is a leading independent British manufacturer of high quality cost effective single use surgical instrumentation and devices partnering with global healthcare providers for positive patient outcomes
Medical apparatus 10 for use with single use kits 100 containing a flow control device 101 a syringe 40 and one or more vials 60A 608 60C for reconstituting a liquid drug dosage and administrating same
SONOTEC is a leading specialist in ultrasonic measurement technology solutions With more than 180 employees the technology company based in Halle Saale Germany develops and manufactures customer specific ultrasonic transducers sensors testing equipment and measuring technology solutions for Non Invasive Fluid Monitoring Preventive Maintenance and Non Destructive
The technical documentation provides information on the design manufacture and operation of a product and must contain all the details necessary to demonstrate the product conforms to the applicable requirements If you are the manufacturer there are certain rules that must be followed when placing a product on the market you must prepare the technical documentation before placing a
Lateral flow testing Lateral flow testing is a fast and simple way to test people who do not have symptoms of COVID 19 but who may still be spreading the virus In some circumstances lateral
Repligen offers turnkey systems for tangential flow filtration TFF single use hollow fiber filters and flat sheet cassettes enable process and cost efficiencies
Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level The Regulations on Medical Devices Regulation EU 2017/745 and on In Vitro Diagnostic Devices Regulation EU 2017/746 changed the European legal framework for medical devices introducing new responsibilities for the European Medicines Agency EMA and national
Live Regulatory Globe s mission is to meet the increasing demands of medical laws and regulations by developing strategies and tools to provide Regulatory Affairs expertise to businesses without deploying expensive resources Our strategies and tools are specifically developed for
A Single Source Partner Nordson MEDICAL Nasdaq NDSN is a global expert in the design development and manufacturing of complex medical devices and component technologies As a single source partner we enable our customers to save costs speed time to market and simplify supply chain management We work with companies at any point in the
for which the use of the centralised procedure is neither mandatory nor chosen by the applicant 2 2 Repeat use It is possible to use the mutual recognition procedure more than once for subsequent applications to other Member States in relation to the same medicinal product so called repeat use
Explore Biotech Products Systems and Solutions From concept through to design biotech validation and production across all biotech applications we can help you adapt to changing market conditions with innovative technologies and solutions Whether that means quickly developing a process for a new drug vaccine production helping you
Medicop is an internationally renowned manufacturer of medical equipment and ambulance vehicles widely recognised across Europe We have available reusable humidifiers as well as single use humidifiers Dimensions W H D and weight of single flow meter 40 155 125 mm 0 45 kg Dimensions W H D and weight of double
The EU MDR 2017/745 has 4 main categories for Medical Devices classification Class I Class IIa Class IIb Class III This goes from the products with low risk Class I to the products with high risk Class III You can find this on the MDR 2017/745 to be preciseChapter V Section 1 Article 51 But if you want to be more specific we can say that there are 3 sub classes under class I
