These factors should also be taken into consideration when determining the scope of documentation to be submitted to the regulating authority when applying for marketing authorization for the medical devices incorporating OTS Software.
It is stated that there is a basic set of documentation to be provided in all cases, while sometimes additional documentation could be needed due to certain specific features of the product subject to review. The document also contains references to the FDA-recognised voluntary consensus standards medical devices manufacturers may use in order to demonstrate compliance with the applicable regulatory requirements.
The information provided in the guidance is closely related to the recommendations contained in the guidance for the content of premarket submissions for software contained in medical devices.
The regulatory approach described therein could also be applied in the context of medical devices incorporating OTS Software. The recommendations provided in the present FDA guidance employ a safety-based approach to risk management and are aligned with the commonly accepted best practices.
According to these standards, the risks associated with the medical devices in general and OTS Software, in particular, should be evaluated with regard to the following factors:. The evaluation of probabilities should be based on the engineering consideration software failure rates , as well as on the clinical data available. The Agency acknowledges that due to the specific nature of software failures, it is quite difficult to evaluate probabilities associated with sufficient accuracy. Thus, the authority recommends focusing mostly on the harm that could be caused to patients or operators as a result of such software failure.
It is stated that hazard analysis constitutes a part of risk analysis. The guidance provides the definitions of the most important terms and concepts used in the context of OTS Software used in medical devices. The terms described in the guidance include the following:. In order to assist medical device manufacturers in applying a risk-based approach in the context of OTS Software, the present FDA guidance outlines the suggested decision-making process to be followed when determining the particular scope of documentation to be provided as part of a premarket submission.
The document also contains a table summarizing the information described hereabove. The guidance further describes in detail the scope of information to be covered by the documentation associated with OTS Software. Basic documentation for OTS Software shall describe the software itself and also provide information about its manufacturer, version, and design limitations. This section should also cover computer system specifications for the OTS Software, controls implemented in order to ensure the software will be used in an appropriate way, the functions the software performs, the way it operates, and also the way the control of the OTS Software would be performed e.
According to the guidance, the medical device manufacturer shall conduct an OTS Software hazard analysis as a part of a medical device system hazard analysis.
Ease of use is the primary consideration of purchasing construction software, even more critical, than functionality, cost, or the ability to integrate with existing software. A tailor-made solution will generate a fast adoption of this new and improved way of working. You can expect huge gains in many areas:.
We believe in the continued support of our solution to ensure our customers are gaining the most from their investment from day one and beyond. Our Team is always there for you to change something or to introduce a new module - fully supporting your needs and providing necessary training for your teams!
For performance, durability, speed, flexibility, efficiency, robustness and style - there is a reason James Bond wears a tailor made suit instead of buying an ill-fitting one off the shelf ;. Keep on top of construction tips, trends and best practices with our weekly article email. You are safe with us. Construction Software 3 November 4 min read. Your choice will depend on a number of factors and questions: Budget available Short and long term requirements Urgency of need Priority to business Complexity and time to implement Features and Benefits that meet the specification The more time, care and consideration spent on choosing the right solution will ultimately have a huge impact on the success of that selection.
Off-the-shelf Software Typically this will be ready to use, plug-in and play software built for a broad user profile range, with a multitude of features aimed at meeting the needs of the market as a whole. Inline Feedbacks. You might also like. At the end of the year, we usually think mainly about the Winter Break and As this year comes to an end, we are reminiscing on all the major achievements Do you know why the prices Sign up!
Find a solution tailored for your business. It empowers users to respond to questions from customers and prospects in real-time, thus promoting instantaneous communication. Besides, managing contacts, deals, requests, and scheduling appointments is a piece of cake with HubSpot Service Hub.
By centralizing customer interactions and details, HubSpot Service Hub makes it easy to monitor sales pipeline activities and the progress of each interaction. This way, agents can convert leads with ease, close more deals, and deliver personalized responses to all customer queries.
The vendor offers a comprehensive free trial to get you up to speed with the features. Help desk software LiveAgent is also a topnotch solution with a comprehensive feature set, mainly its multichannel support. It pulls together live chat, email, and social media to give your customers a choice they prefer when reaching out to you. The app is designed for small business, but can easily scale to enterprise requirements with features for gamification, web-embedded contact forms, and collaboration space.
Small teams can handle volumes of tickets daily with ease by leveraging the unified inbox and smart automation. All tickets are consolidated in one location, preventing missed tickets and allowing for quick spotting of overdue tickets. The app also integrates with your social media pages, mainly Facebook and Twitter; you can post, reply and manage these pages inside the system. And if you want to align the functions with your workflows, the app offers a richly documented open API for third-party apps.
You can use all the features for free for a period of time to see if the software matches your needs. Ticketing management system JitBit HelpDesk is a solution that leverages machine learning to automate customer service tasks. Created for businesses of all sizes, this platform offers a simple and streamlined user interface that makes it easier to track support requests, assign tickets, as well as monitor the overall performance of help desk agents.
Aside from these, JitBit Helpdesk also comes with a unified mailbox that consolidates all service requests and inquiries. This not only makes tracking more convenient for your staff but also allows you to ensures that no message is ever overlooked.
In case these tools are still not enough for your business, this ticketing system is also equipped with a powerful REST API capability. By using this, you can integrate the software with a variety of third-party applications. Be it your existing CRM tool, email, or active directory, this platform is designed to work seamlessly alongside them for a more fine-tuned workflow.
IT help desk software SysAid is a reliable solution designed to help IT businesses manage and resolve technology-related issues. The platform provides a swath of robust features including IT asset management, ticket management, a self-service portal, remote control, knowledge base, and reporting tools.
SysAid streamlines the operations of ITSM teams with automation and intelligent service orchestration. This way, it lightens the load for IT service agents, allowing them to manage problems and incidents with unprecedented ease. Most importantly, users can choose to deploy the software in the cloud or on-premise.
Regardless of how SysAid is deployed, it provides a centralized point of entry for all IT support tickets. In doing so, it allows managers to assign tickets to the available IT technician or adjust the priority to expedite resolution.
The vendor has an appealing free trial where you can tinker with the features at no cost. Furthermore, the software provides effective tracking and notification features.
This way, regardless of the number of problem tickets that are streaming in, nothing gets missed. Even better, with the knowledge base, you centralize and avail relevant information to your technicians and end-users.
In doing so, you empower technicians to handle technological issues more professionally, while giving customers a taste of exceptional self-service. Help desk software TeamSupport is designed for the B2B industry. It lets you consolidate all client interactions in one platform to make it easy to track and manage relationships. A centralized customer database gives you complete visibility on tickets, issues, requests, and conversations. Powerful analytics can digest myriad insights by running the numbers on this database, such as identifying the most common demands of clients.
Likewise, the system has robust ticketing management that features email integration, automated ticketing and custom fields, properties, and statuses to match with your workflows. With the TeamSupport free trial, You can check the solution closely at no cost. Help desk software Hiver is the first platform of its kind to be created for the Google Workspace. It equips your Gmail inbox with features such as workflow automation, workload distribution, collision alerts, activity timelines, as well as a slew of collaboration options.
With this at your disposal, you can easily transform your existing inboxes into a fully-functioning help desk without the fuss of having to learn a completely different platform. It natively connects with business communication platforms such as Slack and it also integrates with third-party systems using Zapier. Moreover, Hiver can be accessed using both desktop and mobile devices for complete flexibility.
An appealing test drive of all software features is available to you through the Hiver free trial. Customer service software ManageEngine ServiceDesk is both a help desk and asset management system ideal for businesses that are new to ITSM-compliant processes. It features code-free configuration and integration, allowing non-technical managers to easily adopt this solution into their workflows.
It works with myriad communication channels and works with all the important OS. Likewise, it allows mobile access and third-party integration to extend its functionalities to other important business systems like CRM, help desk, project management, and business intelligence. An appealing test drive of all software features is available to you through the ManageEngine ServiceDesk free trial.
ManageEngine ServiceDesk is also among the few vendors that offer hybrid setup. The system can be deployed on-premise and cloud and can gradually migrate your processes either way for a smooth transition.
Customer support software Cayzu is an easy-to-use, cloud-based help desk solution built to help SMBs and enterprises deliver exceptional support experience. The platform helps businesses to automate support workflows, interact with customers when they are online, personalize support experience, and generate reports to derive insights that guide decision-making.
It empowers businesses with powerful features like built-in SLA rules, custom rules, customer portals, reports, and issue management. Additionally, Cayzu allows businesses to provide support from multiple channels including email, website, social media, and more. The beauty of it all is that businesses with multiple products can easily create a branded end-user support portal for each product.
Even better, all the end-user portals are configured to feed into one centralized cloud-based help desk dashboard. As a result, the business can protect the unique identity of each product, while allowing the support agents to manage all customer issues from a single location.
You can utilize the Cayzu free trial and try its premium features at no cost and without commitment. The good thing about this platform is that it unifies support, operations, and development in one package so your agents can access everything the customer needs easily and simply. Some of its core features include metrics, real-time collaboration and messaging, SLA delivery, and knowledge base building.
With its open-source interface, it can be tailored to serve any purpose, industry, or business. Jira Service Desk also has a completely free plan, but you can upgrade to a paid plan if you need more functionalities.
Customer engagement software RingCentral Engage Digital , formerly Dimelo by RingCentral, is a reliable digital communication management solution. The platform brings to one interface interactions from all digital channels including social media, messaging apps, live chat, email, and reviews from Google My Business and Google Play.
In doing so, it enables businesses to connect easily with customers where they are online and build stronger relationships. Better still, with RingCentral Engage Digital smart routing, keeping customers on hold is a thing of the past. Even when you get swamped with a wide range of customer issues, the solution allows you to automatically classify and route them to the most qualified agent. As a result, issues are handled conclusively and professionally, leading to increased customer satisfaction.
You can try all its premium features at no cost through the RingCentral Engage Digital free demo. What makes RingCentral Engage Digital unique is the identity merge, a powerful feature built to cut duplicate conversations. Cloud-based help desk software Atera is a robust yet intuitive solution designed primarily for MSPs and IT service providers.
Atera empowers service providers to communicate with their clients and manage and solve the toughest IT problems from a centralized location. The solution offers a help desk and ticketing system, knowledge base, customer portal, and a set of robust Remote Monitoring Management RMM tools in a powerful, all-in-one platform.
Most importantly, the software is designed to be easy to use. It supports rapid onboarding with a flat learning curve that enables support agents to get started with the software with minimal fuss.
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