CitiusTech’s Post

The ultimate guide to Unique Device Identification (UDI) directives for medical devices (and how to comply!) Read our latest news blog here 👇 https://lnkd.in/e-Bfi9PV #ivs #industrialvisionsystems #udi #medicaldevices #medical #compliance #engineering #professionals #visionsystems

🆕 New entry at Asphalion’s MedTech Blog | Changes in Medical Device Regulations: Navigating the New Landscape 🔝 Have a look at the latest entry of ASPHALION’s #MedTechBlog!   ↪ In this post, ASPHALION expert Adi Ickowicz delves into some of the latest #updates and discusses upcoming #changes to #medicaldevice regulations, analyzing their potential impact on both manufacturers and the #healthcareindustry.   ↪ The ever-evolving world of #medicaldevices is not just limited to #technological advancements; medical device regulations are constantly adapting to ensure the #safety, #performance, and #efficacy of medical devices for #patients.   👀 Have a look at the new entry here: https://bit.ly/3Mx9DVc   📧 For further information, you can contact us at: medtech@asphalion.com 📆 Or schedule a free 30-minutes meeting here: https://bit.ly/3NwVsNR   #RA #MD #Device #DeviceSafety #DigitalHealth #MeetTheExpert #WeAreAsphalion #WeCare #KnowledgeFromExperience

https://lnkd.in/gPB39Dzb A simple question, who really oversees medical device design as it relates to risk? Certainly not the regulatory agencies like FDA. Yes it is stated in the regulations and subsequently paper is produced or you will documents immortalizing acts concerning design history. If no documents are produced or "inadequate” whatever that means (mostly FDA’s call) then the firm is cited, more importantly if problems arise after commercial action then a retro active FDA investigation occurs and the agency cites design controls mostly on the evidence that arises after the failures. You must have designed it wrong otherwise we would have these problems and so on. An easy escape responsibility we are doing something move for the agency. A serious design failure is a gift from Mr. Risk that keeps on giving all the life of the device and sometimes after. That said the only one that really oversees design controls proactively and retroactively is the one that was there from inception of the medical device, Mr. Risk, everyone else including the FDA is reactionary.

Very insightful views from our Global Director of Medical and Laboratory business about the emerging trends that are reshaping the MedDev industry, and the crucial role industry Standards play in advancing the development of high quality and safe medical devices. #MedDev #WorldStandardsDay #NewTechnologies https://lnkd.in/d7bjiiys

Results from a study commissioned by the European Commission show that just around a third of interested countries are applying national rules or Common Specifications in order to reprocess and reuse single-use medical devices. #eipgeu #repurpossing #reuse #medicaldevices https://lnkd.in/drmB6tgt

Are you having trouble ensuring patient safety while maintaining development efficiency with your #MedTech products? For #medicaldevicedevelopers, speed and safety are the two most important factors for #MedTechinnovation. Devices must perform, hit the market quickly, follow rules and regulations, and keep patients safe. But how do we accomplish all of those important measures in such a short amount of time and still ensure we're bringing effective devices to market? In this post, we’ll cover all the stages of developing your next medical technology device, from #patientsafety to #regulatorycompliance. http://ptc.co/mYSi50Q3zVe

It’s so disheartening to see, manufacturers of medical devices - ignoring the early warning systems that their process are designed to raise. With the inevitable consequence of catastrophic failure. I don’t believe the right thing is to move to a world where everything is rigorously tested by authorities which would slow down innovation, slow down market access, bring cost up, and everyone’s favourite, the slow beurocratic death. But management must not sweep the red safety flags under the red profits and growth carpet. Risk cannot be totally eliminated, but with the right tools, knowledge and culture it can be managed and prevented from catastrophic consequences. If you’re looking for expertise to support on this topic- we’re here to help https://lnkd.in/eup9VSA5

Ultrasound machines are a valuable tool for healthcare professionals, but it's important to be aware of the licensing and regulations that apply to their use. This article from Medical Search Australia provides an overview of the relevant laws and guidelines, so you can be sure that you're in compliance https://lnkd.in/gpxeVTQ3

Recent US policies have been designed to expedite medical device approvals. These changes are set to accelerate the introduction of groundbreaking medical technologies, ultimately enhancing patient care and outcomes. Read the full article to understand how these new policies are transforming the medical device landscape in the US. #MedicalDevices #HealthcareInnovation #PolicyChanges #PatientCare #HealthTech

By developing and implementing a comprehensive repair strategy, medical device manufacturers can effectively address these challenges. This strategy should be flexible, adaptable to evolving regulations and technologies, and focused on maximizing device reliability, compliance, and customer satisfaction throughout the product lifecycle. Let's talk #repair! #shyftglobalservices #maketheShyft #MedTech #HealthTech