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Do you know what pitfalls most medical device manufacturers are experiencing as they RUSH to get their devices approved?nn1. Using old documents and records thinking they will be approved.n2. Getting Nonconformance / Deficiency Reports.n3. Proper use of Harmonized Standards and Common Specifications.nnBy attending this webinar you will learn how to help avoid these, and other pitfalls, and make your company’s technical documentation preparation and approval as seamless as possible. nnAbout
Webinar- Transitioning from MDD to MDR – Pitfalls to Avoid 2.3.23
⏲ 29 min 28 sec ✓ 04-Feb-2023
Quality Regulatory Specialists
What Are Harmonized Standards Under EU MDR And EU IVDR?
⏲ 5 minutes 39 seconds 👁 122
CEN and CENELEC
Webinar 'Harmonized Healthcare Standards' - part 1.
⏲ 52 minutes 54 seconds 👁 141
From the perspective of appearance, the overall design of Yuanhang H8 is family<br/>It uses a stylish design language and the overall appearance offers a simple and atmospheric visual experience. Its front face has a complete look, with a wider hood protruding out from both sides and a blacked-out air intake under the grille that continues to expand the visual impact. The grid uses a closed design commonly used in current new energy models. The inner crystal shape of the headlight clusters on both sides is a relatively rare design in the current market.<br/><br/>The use of aerodynamic lines on the side of the body increases the fluidity of the vehicle. While frameless doors and hidden door handles increase the visual impact of the vehicle, the wind resistance coefficient of Yuanhang H8 as a large SUV is also reduced. It is only 0.27cd and that is why the wind resistance coefficient is only 0.27cd. This is one of the ways to reduce air resistance and save electrical energy.<br/><br/>The back part is relatively rounded, and three sets of segmented light sources are used on each side of the transition-type light strip, which is quite recognizable when illuminated. It adds sportiness to the vehicle.<br/><br/>As a large SUV, its wheelbase reaches 3126 mm, and the length, width and height of the vehicle are 5230 * 2015 * 1760 mm respectively. Moreover, it internally adopts 2+2+2 seating arrangement to meet the needs of more travel scenarios.<br/><br/>In terms of visibility, it is equipped with a 12.3-inch full LCD display and a 17.38-inch vertical central control screen, allowing users to see vehicle information more conveniently and clearly while driving.<br/><br/>All Yuanhang H8 car-machine chips are standard equipped with Qualcomm Snapdragon 8155, which can realize in-car display interaction. In addition, Yuanhang H8 adopts smart dimming canopy double silver plating process, which can effectively isolate 99.9% of ultraviolet rays and more than 80% of infrared rays, while 27 high-quality speakers combine with wanos panoramic sound effects, allowing the user to listen improves your experience. .<br/><br/>It is divided into rear-wheel drive and all-wheel drive models. The rear-wheel drive version is equipped with a drive motor with a maximum power of 250kW and a peak torque of 400N·m and is adapted to 81kW·h and 88kW. Pure electric cruising range under CLTC operating conditions is 560 kilometers and 610 kilometers respectively. Official acceleration from 0 to 100 seconds is 6.5 seconds.<br/><br/>The four-wheel drive version models with a range of 560 km and 650 km use 88 kWh and 98 kWh triple lithium batteries as energy storage devices, respectively, and adopt a dual-motor layout. The maximum power of the front engine is 250 kW. The peak torque is 345N·m, the maximum power of the rear motor is 250kW and the peak torque is 400N·m. <br/><br/>Source: https://www.pcauto.com.cn/hj/article/2462123.html#ad=20420
950 Km Range, 0-100 Acceleration in 3.8 Seconds , New Yuanhang H8 Premium Edition SUV 2024
⏲ 4:53 👁 20K
Star Rapid
Why you need ISO 13485 for your medical device manufacturing project
⏲ 5 minutes 8 seconds 👁 7.4K
Eurofins Medical Device Testing
Changes in Europe’s Medical Device Regulations: Consequences for Manufacturers
⏲ 52 minutes 19 seconds 👁 1.7K
As a new model, Beijing EU5 PLUS R600 Premium Edition maintains the appearance of the current model, emphasizing the sense of power with the raised line design on the bodywork.<br/><br/>The front face adopts the fold line design concept to create a sense of hierarchy; The center grille is also adorned with chrome trim strips running through the headlight clusters on both sides. On the side of the car body, the arched waistline runs from the front to the rear of the car.<br/><br/>Official guide price range: 129,900-185,900 Yuan ($18,320-$26,300()<br/><br/>The rear of the car is equipped with a ducktail and full-length taillights that look quite full and thick. Additionally, brand letters are added between the ducktail and taillights to highlight the brand identity. In terms of body size, its length, width and height are 4670/1820/1520 mm respectively, and its wheelbase is 2670 mm.<br/><br/>Inside, it adopts a simple design style, using a dual 12.3-inch large connectivity screen and a yacht-style electronic gear lever. Compared with the special version of the R600 series, it is 9,000 yuan more expensive, mainly due to the addition of home charging components and vehicle-mounted emergency firefighting medical kit configurations.<br/><br/>addition of front and rear side airbags, forward collision warning, etc. It has more comprehensive active and passive security such as Also standard are 360-degree panoramic views, full-speed Adaptive cruise control, external discharge and external rear vision Features include electric folding/heating of mirrors, wireless charging for mobile phones, lumbar support for the main seat, heated/ventilated front seats, electric front passenger seat It has 10-color interior lighting features.<br/><br/>In terms of power, it is equipped with a single-motor drive system with a maximum power of 120kW and a maximum torque of 240N·m. The 60.7 kWh NEDC pure electric cruising range is 501 km. It also has a fast charging feature and it takes half an hour to charge the battery from 30% to 80%.<br/><br/>Source: https://www.pcauto.com.cn/hj/article/2348831.html#ad=20420
Supporting Fast Charging, 501 Km Range , New Beijing EU5 PLUS R600 Premium Edition 2024
⏲ 3:25 👁 5K
Stanford Biodesign
What's going on with the harmonization of regulatory standards across geographies?
⏲ 3 minutes 51 seconds 👁 86
Medical Device HQ
Design Control for Medical Devices - Online introductory course
⏲ 17 minutes 31 seconds 👁 30.3K
A total of 4 models of the new GAC Trumpchi Shadow empow were launched on May 1. As a renewed model, the new Shadow Leopard has been developed in five main dimensions: appearance, interior, technology, performance and safety. In terms of power, two sets of four-cylinder engines continue to be available, the 1.5T and 2.0T.<br/><br/>Official guide price range: 108,000-158,000 Yuan ($15,000-$21,900)<br/><br/>In terms of appearance, it continues the overall design of the current model. The overall shape is sportier and body details have been greatly improved. The front frame was darkened. . At the same time, all models are equipped with Michelin tires as standard, while mid-range and lower-end models are equipped with the Michelin PS4 series with 225/45 ZR18 tire specifications, and high-end models are equipped with the Michelin PS5 series with 225/45 ZR18 tire specifications.<br/><br/>It also introduces four new body colours: ivory white, elegant black, Haoyue Grey, Super Star Silver and matte Haoyue Gray with Super Star Silver being a new colour.<br/><br/>In terms of body size, its length, width and height are 4700 (4753)/1850/1432 mm respectively, and its wheelbase is 2736 mm.<br/><br/>In terms of the interior, the layout design of the current model is also continued with the addition of white and blue interior styling and fine-tuning of the decorative panel texture, making it look more sporty and luxurious at the same time. In terms of design, the new car is equipped with a 10.25-inch full LCD display and a 10.25-inch dual screen. Moreover, it adopts a pass-through type air conditioning outlet design and is equipped with a three-arm flat bottom.<br/><br/>In terms of intelligence, it is equipped with ADiGO smart vehicle network ecosystem, which can directly interact with the vehicle through intelligent voice control functions to control various functions of the vehicle, such as multimedia, navigation, telephone, air conditioning. sunroof etc.; Additionally, the remote vehicle control function allows users to control the vehicle remotely via smartphones or other mobile devices. In addition, all new car series are equipped with the Carplay interconnection function as standard, ensuring a seamless connection between mobile phones and vehicles.<br/><br/>In terms of configuration, it comes standard with an 8-speaker Yamaha sound system, 540° panoramic parking view (including transparent chassis) function, 32-color ambient lighting, heated front seats and rear air conditioning.<br/><br/>In terms of power, it continues to offer two sets of four-cylinder engines, 1.5T and 2.0T. Shadow Leopard S version and Shadow Leopard R-Style version are equipped with 1.5T engine with maximum power. It provides 177 horsepower and 270 Nm of maximum torque. Combined with the 7-speed dual-clutch transmission, the official acceleration time from 0-100 km/h is 6.95 seconds, the top speed can reach 200 km/h, and the WLTC comprehensive fuel consumption is as low as 5.96L/100km.<br/><br/>Source: https://www.pcauto.com.cn/nation/4263/42633907.html#
With Appearance, Interior, Technology and Performance Upgrades , New Trumpchi Shadow Empow R 2024
⏲ 3:30 👁 5K
Medical Device HQ
Documentation for a medical device product development process (Part 1)
⏲ 11 minutes 26 seconds 👁 8.4K
Mantra Systems
How to build a winning strategy for EU MDR Compliance & Medical Device Regulatory requirements
⏲ 1 hour 5 minutes 19 seconds 👁 3.4K
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