Medical Device Design and Development (MD3) LLC的动态

Why is understanding your software build so important?? A lot of medical software, be that SaMD or SiMD are built on legacy code as well as SOUP.? This is all well and good, but what happens when the architecture is poorly documented, or there is no understanding of dependencies, integration or the detailed design…….a Change Control nightmare! Having a very clear understanding of the “left hand side of the V model” will help reduce the fall out when Change Control needs to be implemented in software, especially in released software. Otherwise, your software may just resemble a kitten with a ball of string!? Requirements: Ensure all stakeholders have input into what the software needs to be and do. Ensure that these are signed off, and that there is no creep in them. Architecture: Having a high-level multilayer map of what the software, hardware, integration, and networks looks like will help the team “see” what they are building and how it all pieces together (or at least should piece together) Detailed Design: Understanding how each software requirement is broken down into components, items, and units and how they are to be built.? Traceability: Of course, ensuring that there is a mapping between requirements to the building blocks will also help with implementation of changes.? In short, ensure you know what foundations your software product is built on, and how your product is built, and it will save you so much time and money in the end.? xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx ??At Fieldfare Consulting we help innovation thrive.? ??We provide quality, regulatory compliance and data security consulting services for companies in medical devices, IVD’s including digital health and femtech.?? ??Contact us via DM for further information and help.?? #medtech #medicaldevices #digitalhealth #femtech #regulatorycompliance #qualityassurance #datasecurity #cybersecurity #fieldfareconsulting?

Navigating Challenges in Developing Software for Medical Devices --------------------------------------------------------------------------- PART 5: HOW TO SECURE DATA AND PROTECT PRIVACY IN MEDICAL DEVICE SOFTWARE Developing medical device software that maintains the security and integrity of patient information is a significant challenge. Our team can help mitigate concerns about vulnerabilities within your product by implementing robust encryption, access controls, and authentication mechanisms.? Our Agile methodologies ensure that security checkpoints are baked into every phase of development. Learn more about our approach to ensuring security of the data within your medical device: https://lnkd.in/ecauJWJm ?? How do you think patient and data security risks will continue to increase as technology advances? ??

BEACON C610W, 37.5” 6MP Integrated Three-screen Display：??????????????????? Backlight Stabilization System Primary Screen Adaptation Continuous Quality Assurance System Compliant with DICOM Standard Ambient Light Adaptive System Independent Gamma Function Uniformity Calibration Technology QA Software

?????????? ???????????????? ?????????????????? ???? ???????????????????? ?????????????? ??????????????? With the publication of MDR, some new basic safety requirements have been established for all medical devices containing electronic programmable systems and software that are themselves medical devices. Data security, network security and software security and Cyber security risks should be identified and secured in medical devices.? Software and cyber security risks should be reviewed as these circumstances:?? ?electronic programmable systems,? ?software that are devices in themselves,? ?the devices that are including software? ?in particular where the processing involves transmission over a network. GDPR is also part of these security risks. It should be noted that the review should be carried out throughout the life cycle of the device. Additionally, Manufacturers shall set out minimum requirements concerning hardware, IT networks characteristics and IT security measures, including protection against unauthorized access, necessary to run the software as intended. There are many resources regarding cyber security. Some of the guidance is as follows:? ?MDCG 2019-11 Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR? ?MDCG 2019-16 - Guidance on Cybersecurity for medical devices? ?ISO 81001-1: Health software and health IT systems safety, effectiveness and security? ?IEC/TR 80001-2-x: Application of risk management for IT-networks incorporating medical devices?? ?IEC 81001-5-1: Health software and health IT systems safety, effectiveness and security Part 5-1: Security Activities in the product life cycle? IMDRF/CYBER WG/N60: Principles and Practices for Medical Device Cybersecurity? ?IEC 62304: Medical device software - Software life-cycle processes? ?IEC TR 60601-4-5 Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications (Related with IEC 62443) #KiwaMedical?#MedicalDevices?#Kiwa?#MDR

Extremely Disappointed with PTCL Customer Service: A Warning for New Customers! If you're thinking about getting a new PTCL connection, be warned: they may take your payment and then disappear, leaving you without the service you paid for. Here’s my experience: I applied for a new internet connection and received an order confirmation email shortly after. I was asked to make the payment, which I did, expecting quick installation. However, it’s now been nearly a month, and there’s still no sign of my connection. Every time I contact live support, they open a new ticket and assure me their "dedicated team" is working on it. It’s starting to feel like setting up a connection with PTCL is as complicated as heart surgery! Here are the connection details and the tickets generated by their team: Order ID: 1-365648646277 Ticket No.: 4163285 Ticket No.: 4166236 Ticket No.: 4167747 Despite this, I keep receiving the same automated response day after day: “Our dedicated team is working on resolving your issue. We apologize for the inconvenience.” If you’re considering PTCL, think twice. I’m deeply frustrated with their lack of progress and transparency. PTCL.Official PTCL | UFONE Business Solutions PTCL Customer Care

Recently an early professional reached out to me expressing disappointment of not working in the Software As a Medical Device (SaMD) space. I know a lot of them feel the pressure to work in the #SaMD space. I did too. But the moment I worked on SaMD product, I did not enjoy it. Despite knowing myself well, I put myself in this position only because I thought it was the next big thing. It wasn't a pretty mistake! Yes, SaMD/AI/ML maybe the next big thing but so is everything else today. Right from #Fashion to #SoilScience to #Cybersecurity, everything is complex and challenging. I particularly find #interoperable devices fascinating. Interoperability is the ability of different systems being able to talk to each other without loss or manipulation of information. All components have to work together to meet the intended use. How fascinating is that? If you're someone who is awed by how different machineries/industries work, if you can form connections between different subjects and simplify those concepts then it is absolutely unnecessary to push yourself towards #SaMD. Hardware is still the medium of technology delivery and it is here to stay. Be it infusion pumps, continuous glucose monitors or surgical devices w/o interoperability these devices are useless. Besides, even today, a manual, non-software device is still a reliable backup when software fails or is hacked. I now realize it's not about the tech. It is about the role, relationships and recognition within the organization! ??

I sometimes lose sales to lesser products It goes something like this: Discovery software "I can do this with ChatGTP, Excel, Zapier and my cousin Dorita on the weekends for half your price!" Pioneer compactor monitor "There are other systems that are less expensive" I welcome this for 3 reasons. Why? 1) The other systems look horrible to use (can confirm that their past users tell me they are). This helps me in the long run bc the users come to hate these inferior systems that look like Windows DOS. 2) They perform poorly (manual management, no prediction, "automation" means they send an email for you to manage). This helps me because, again, poor performance is long remembered after cheap price has faded. 3) we win our share of converts through our existing customers growing and taking over these accounts with our promise and proof of better software and service. Our customers love our products, and understand the value premium > cost premium.

Sekyo Innovations What a pathetic experience! How you guys still exist as a company is beyond me! We ordered a watch from you guys for my kid, the video call feature wasn't working at all, so we sent it back. That pick up was done promptly! But the replacement watch didn't reach us at all! It was sent through DTDC and shows delivered, but no one came to our building or society, there's no entry for it in security registers! Where is the product? And why won't you just give a straightforward refund?? What is this shady behaviour? And your "customer care" says you'll are investigating the matter! It isn't a murder investigation, just send me a replacement through hand delivery, so this time you know there won't be any foul play OR refund the damn amount! It really is that simple!! Sort out whatever you need to sort out with the courier company after that, at your own pace, I couldn't care less! Why make the customer suffer?? We're following up with the courier company and with your company too! And you'll have the gall to keep advertising the product on Instagram?? Shameless! Everyone on my list who sees this, please share this widely! Smridhi Goyal Sekyo DTDC Support

If you are considering leveraging AI to improve your customer support but are hesitant about having it interact directly with customers, consider using it as an "Agent Assist" feature. This approach is extremely powerful and can significantly enhance your support offering. AI is not only a tool for direct customer interaction; it is also a valuable asset for assisting your agents in providing better support. Here are some of the many ways AI can benefit your service organization: And if you're not sure where to look or start on such a journey, message me and I can provide some recommendations. ?? ?? AI can provide real-time support to agents by suggesting responses, pulling up relevant information, and guiding them through complex issues. ?? AI can automatically log interactions, summarize conversations, and update customer records, reducing the administrative burden on agents. ?? AI can analyze interactions to identify common customer pain points, preferences, and behaviors, providing valuable insights for improving products and services. ?? AI is great at summarizing emails from customers and doing a "pulse check" to ensure the issue is being addressed, alerting the agent of any issues. ?? AI can track and analyze agent performance metrics, helping managers identify areas for improvement and training needs. ?? AI can help agents personalize their responses. ?? AI can analyze the sentiment of customer interactions, allowing agents to better understand and respond to customer emotions. ?? AI can continuously monitor interactions for quality assurance, ensuring that service standards are met and identifying areas where agents may need additional training. ?? AI can help analyze agents' responses and prevent errors (spelling, tone, incorrect issues, etc.). ?? AI systems can detect patterns indicative of fraud or suspicious activity by agents, providing an additional layer of security. ?? AI can ensure compliance with data protection regulations by securely handling customer data and automating compliance checks. ?? AI can translate incoming tickets, breaking down language barriers and enabling better service for a global customer base.

From Recalls to Reliability: Tools to Ensure Software Safety in MedTech – MedCity News - MedCity News #Recalls_in_MedTech From recalls to reliability: Tools to ensure software safety in MedTech #Introduction Healthcare IT professionals must prioritize software safety in MedTech to prevent recalls and ensure reliability. #Recalls_and_Reliability Recalls in MedTech can be costly and damaging to a company's reputation, highlighting the importance of reliability in software. #Challenges_in_Software_Safety There are various challenges in ensuring software safety in MedTech, including regulatory compliance and cybersecurity threats. #Tools_for_Software_Safety Healthcare IT professionals can utilize tools such as automated testing, code reviews, and risk management frameworks to enhance software safety in MedTech. #Regulatory_Compliance Adhering to regulatory requirements ai.mediformatica.com #software #medical #tools #medcity #safety #medicaldevice #devices #healthcare #news #medtech #patientsafety #medcityinfluencers #digitalhealth #healthit #healthtech #healthcaretechnology @MediFormatica (https://buff.ly/3Vm1gPL)