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Medical Device Related Regulations. Medical Device Software Document released version (article 5.8.4) Hello: I have a question, my company is in the process of get the CE mark for a medical device IIa class according with directive 93/42/ECC.
We include at the device an own software for refraction measuring. Our software is class A according with IEC 62304, so, we need to incorporate the document released versions. But I have a doubt about how to organize the semantic of number versioning. We start the software with 1.0.0 version, of course, but with time, some different projects have emerged, it means, with the base at 1.0.0 version we have created some different versions of the same software for custom properties, depends on clients. IEC 62304:2006: Medical device software SDLC- CE Vs. Fda 510(k) submission. IEC 62304:2006 Checklist .xls file attached - Page 2.
IEC 62304 - Medical Device Software Life Cycle Processes. IEC 62304 Software Development Plan. Do you have a defined and documented development process?
You must if you are following the QSR. In this case you have the majority of the software development plan already done. The development procedures are the core of your plan. The Plan document is then the information that has not been proceduralized such as, what the project's goals are, what functionality is to be included in the project, the actual development project schedule, where documents will be stored, who is involved (often part of the schedule as well), what testing will be done, etc. I view plans as containing the information needed by the team to complete the project successfully from an administrative point of view. 62403 is written from the perspective of not requiring documented procedures. Medical Device Software Development Procedure. Quality Assurance & Business Systems and Standards Information - The Elsmar Cove.
Templates Repository for Software Development Process - Software in Medical Devices. I gather here all the templates I built about system and software development process.
I sort them according to the main tasks found in system and software development process: System Requirements Analysis,System Architecture and System Interfaces Design,Software Requirements Analysis,Software Architecture and Software Interfaces Design,Software Detailed Design,Coding, coding, coding and coding,Unit Tests and Software Components Tests,Software Integration and Tests,System Integration and Tests,Delivery,System Validation. This page is still under construction. Applying IEC 62304 Risk Management in Aligned Elements - the medical … MDevSpice is a one-stop shop for medical-device manufacturers. Medical devices such as pacemakers are almost taken for granted these days.
They greatly improve quality of life and most people have them fitted and think no more about it. However, many of these devices are underpinned by complex software and sometimes it goes wrong. Not surprisingly those developing safety critical software have to jump high regulatory hurdles. Up to now this meant wading through masses of different rules, regulations and standards. Bringing Medical Device Software Development Standards into a single model - MDevSPICE® Dr.
Fergal McCaffrey (Lero@DKIT) The global medical device market is currently valued at $315 billion and is forecast to reach $362 billion by 2015. A steady growth between 4 and 6% is expected in most countries worldwide with a particular increase in China and regions where an increasing aging population is prevalent. Antenatal Care. Antenatal Care Services What antenatal care is available?
If you think you are pregnant, the first step is to visit your GP, who will confirm your pregnancy, estimate the date your baby is due and discuss your plans for antenatal (pre-birth) care. In Ireland, all expectant mothers are entitled to free maternity care, covering antenatal visits, labour, delivery and postnatal care. Antenatal visits. Generally, you will have approximately 8-10 antenatal appointments with your doctor or midwife during your pregnancy.
You may visit your GP, antenatal clinic or midwife monthly until 32 weeks, fortnightly after that and you may have weekly visits in the last month. UXPressia. Digital customer experience mapping. Digital customer experience mapping. Commercial Software for Customer Journey Mapping? UX360 - Customer and User Experience Software Tools. Service and System Design Toolkit. Patient Perspectives. Back to previous page What is it and how can it help me?
There is no one right way of collecting patients’ views; different methods suit different purposes. However, it is important that you use a method appropriate to the group of patients involved, and the planned service improvement. This guide describes four different methods of obtaining patient perspectives: questionnaires, focus groups, semi structured interviews and patient shadowing.
When does it work best? Each method works well in a different situation. It is often those closest to the process who are best placed to give useful feedback on the way services work and how they can be improved. How to use it Some general rules Always have clear objectives: what are you trying to achieve? The four methods 1. When to use it Questionnaires are useful for measuring baseline information and to evaluate change over time.
Readyset.tigris.org. Mayo Clinic tests do-it-yourself prenatal care - StarTribune.com. On the morning of her doctor appointment, Andrea Pedersen had stopped at the gym to check her weight and blood pressure.
She noted her measurements on her iPhone, and at the appointed time, she headed to a computer for a video chat with her physician. Altogether, she admits, it wasn’t the typical prenatal visit. But it may be by the time her 7-month-old daughter, Anna, grows up. Neova Health. Cancer Patient Journey - Blue Latitude. Sample_patient_journey_map_final.jpg (JPEG Image, 1279 × 865 pixels) - Scaled (80%) Franklin Andrade - UX & IxD designer. Pregnancy Journey Map by James Lewis. Long-scroll pregnancy journey model. UX STRAT 2013 Workshop Reviews.
By Pabini Gabriel-Petit, Margie Coles, and Lisa Hansen Published: September 23, 2013 “The inaugural UX STRAT conference began on September 9, 2013, with a full day of pre-conference workshops. Google Image Result for. Mapping the customer experience with customer experience journey maps. Consumer Journey Mapping: Reaching Patients at Critical Decision Poin… Journey mapping as insight tool - a healthcare case study UXLX 2012. How Technology-enabled Care Models Can Help Fix Healthcare’s Greatest… Untitled. Primary Outcome Measures: Expectant mothers satisfaction of prenatal care [ Time Frame: 36 weeks ] [ Designated as safety issue: Yes ]At 36 weeks the expectant mother will complete a survey that assessed their satisfaction of the prenatal care received using a validated scale. OB Nest is a model designed to promote increased patient-centered care during pregnancy.
OB Nest care will allow for more flexibility, decrease interruptions to your productivity, while continuing to maintain safety for you and your infant. This model of care is anticipated to allow you more access to your health care team during your pregnancy. This study will compare OB Nest, a new model of prenatal care, to the existing traditional model of prenatal care. Ob-nest-experiment-report. Ob-nest-experiment-report. Ob-nest-connected-care-model.pdf. Patient journeys: the process of clinical redesign. Redesigning services around patients and their doctors: the continuing relevance of lean thinking transformation.
51_SSC_PSP_Process_Mapping.pdf. Searching for the missing pieces between the hospital and primary care: mapping the patient process during care transitions. + Author Affiliations Correspondence to Dr Julie K Johnson, Faculty of Medicine, Centre for Clinical Governance Research, University of New South Wales, Sydney, NSW 2052, Australia; firstname.lastname@example.org Accepted 27 September 2012 Published Online First 1 November 2012 Abstract Background Safe patient transitions depend on effective communication and a functioning care coordination process. Evidence suggests that primary care physicians are not satisfied with communication at transition points between inpatient and ambulatory care, and that communication often is not provided in a timely manner, omits essential information, or contains ambiguities that put patients at risk.
Process mapping the patient journey: an introduction. Timothy M Trebble, consultant gastroenterologist1, Navjyot Hansi, CMT 21, Theresa Hydes, CMT 11, Melissa A Smith, specialist registrar2, Marc Baker, senior faculty member3Author affiliationsCorrespondence to: T M Trebble email@example.comAccepted 15 July 2010 Process mapping enables the reconfiguring of the patient journey from the patient’s perspective in order to improve quality of care and release resources.
This paper provides a practical framework for using this versatile and simple technique in hospital. Healthcare process mapping is a new and important form of clinical audit that examines how we manage the patient journey, using the patient’s perspective to identify problems and suggest improvements.1 2 We outline the steps involved in mapping the patient’s journey, as we believe that a basic understanding of this versatile and simple technique, and when and how to use it, is valuable to clinicians who are developing clinical services.
Homepage of Marina V. Velikova. Software Engineering Project—Personal Health Monitoring. Wireless Blood pressure Monitor. Amazon.com: e-Health Sensor Shield V2.0 for Arduino and Raspberry Pi [Biometric / Medical Applications]: Toys & Games. [android-platform] How to use Android as a HID device(Mouse/Keyboard/gamepad) using Bluetooth HID Profile for connect to PC/XBox/Wii ? It appears you are novice in Bluetooth technology and the related protocol stacks. For your need, you should be focusing on custom Android Firmware, with your HID/input driver changes (most likely at the Linux kernel level). Please read more of HID profile specs and check your feasibility. Regards,Jayanta Sent from my BlackBerry® PlayBook™www.blackberry.com.
Bellabeat Lands $4.5M Seed Round To Grow Its Quantified Self App For Pregnancy. Bellabeat, the startup that launched earlier this year with a system to help moms-to-be to track their pregnancies, has closed on a $4.5 million round of funding. USB On-The-Go. USB On-The-Go, often abbreviated to USB OTG or just OTG, is a specification first used in late 2001, that allows USB devices such as digital audio players or mobile phones to act as a host, allowing other USB devices, such as USB flash drive, digital camera, mouse, or keyboard to be attached to them.
Use of USB OTG allows those devices to switch back and forth between the roles of host and client devices. For instance, a mobile phone may read from removable media as the host device, but present itself as a USB Mass Storage Device when connected to a host computer. How the Scanadu SCOUT Works. Scanadu When the crew of the Enterprise travel back in time in “Star Trek IV: The Voyage Home,” Dr. Diagnostic-Maker Scanadu Lands $35M As FDA Submission Nears. 23andMe Ticked Off FDA Regulators. How Smart Health-Care Startups Win Them Over. During the government shutdown last fall, a slice of the Silicon Valley startup crowd was almost gleeful at the fact that they didn't know what was going on in Washington and didn't think it was their job to care. How to Build a Health Care Startup.
With $35 million, Scanadu seeks approval for its medical 'tricorder' Scanadu, a company that is making a handheld device that measures five vital signs in about 30 seconds, has raised $35 million in a funding round led by China’s Tencent and Fosun International. How does the FDA 'approve' medical products? Medical News Today. Connected Health. Blood Pressure : How to choose the right blood pressure monitor. Blood pressure monitor Please note that Blood Pressure UK no longer sells blood pressure monitors or recommends particular companies or specific models. Bmj. British Hypertension Society. Monitors for Self-measurement of Blood Pressure (SBPM) CRADLE - Maternity Worldwide. Developing Medical Device Software to IEC 62304. Simplifying IEC 62304 Compliance for Developers. I-MEWS: Danger signs should not be ignored.
The design, implementation and evaluation of the I-MEWS system aims to ensure patient safety is central in the delivery of quality care The Irish Maternity Early Warning System (I-MEWS) is a nationally agreed system that was developed for the early detection of serious illness in pregnancy and the postnatal period. Home Blood Pressure Monitoring. British Hypertension Society. Monitors for Self-measurement of Blood Pressure (SBPM) Neova Health. NHS England Open Source Open Day - open-eObs.
Download and view T4SKR - open-eObs for Android. NHS England Open Source Open Day - open-eObs. Openeobs. Ob-Gyn EMR Software for Obstetrics and Gynecology medical practice management - NewCreationIT.com-Electronic Medical Records. Healthcare IT solutions and services. India Outsourcing. EEPDtalk - Hand Held Maternity Records. Default. Scottish Woman Held Maternity Record (SWHMR) The Electronic Encyclopaedia of Perinatal Data. Scottish Woman Held Maternity Record. Scottish Woman Held Maternity Record.