Business

A Complete Information of Global Unique Device Identification Database GUDID

Published

2 months ago

September 28, 2023

Where can hospitals, clinicians, patients, researchers and interested stakeholders access information about a particular medical device? The Global Unique Device Identification Database (GUDID Services), administered by the FDA, serves as this database by providing a comprehensive reference catalog for each medical device with a Unique Device Identifier (UDI).

The database only includes information important to the identification of devices and does not include any information identifying a patient. All 64 data elements required by 21 CFR 830.310 (directing electronic records to be maintained or submitted to the FDA) are included.

Some of the key benefits is the ability to facilitate quick and accurate medical device identification, removing potential confusion about device use. High standards for accurate data to be submitted and ensuring product accuracy for downstream users is also another crucial benefit. Top-tier device manufacturers are pairing the UDI together with the digital thread for end-to-end traceability of their data.

Table of Contents

History of GUDID

The FDA established the UDI system in 2013, requiring medical devices to include a device label in a machine and human-readable format. Within the UDI system, GUDID was created as a foundational database used to store medical device product information associated with the UDI. The database officially launched in December 2013, with the public access portal, AccessGUDID, available in May 2015.

Data submission requirements have been deciphered by the medical device risk class, with various deadlines for compliance. Class I medical devices were originally required to be submitted to the GUDID by September 24, 2020, however, unforeseen supply chain shortages from the pandemic delayed this submission requirement to September 24, 2022. See the timeline, below.

September 24, 2014 – Class III devices
September 24, 2015 – Implantable, life-supporting, or life-sustaining (I/LS/LS) devices
September 24, 2016 – Class II devices
September 24, 2022 – Class I devices

Who Needs to Submit Data to the GUDID?

Mandated by the FDA, medical device labelers are required to submit data records for medical devices marketed in the United States to the GUDID. The FDA Final Rule provides a thorough definition of a labeler. As defined, the labeler is the entity that applies or modifies the label and brings the device to market under its brand. Typically, this consists of the medical device manufacturer, however it may also be the specification developer, device distributor, reprocessor, repackager or relabeler. The regulatory or compliance team of a medical device company is usually responsible for determining if they constitute as the labeler, per FDA’s definition.

If more than one entity is involved in bringing a medical device product to the market, the labeler responsible for submitting product data must define this joint venture in a written agreement. Duplicate submissions should be avoided and failure to submit product data altogether may result in both entities being held accountable to the FDA.

Also Read: To know the best employee engagement software read the blog.

What Data Must Be Submitted?

A total of 64 data elements are required for submission, with 57 submitted by the labeler and 7 populated by the FDA. The FDA has provided a spreadsheet of data requirements. Note, only the Device Identifier (DI) portion of a UDI code is submitted to the GUDID, per FDA guidance.

The required specifications for GUDID submission embody all of the device information available in the UDI, including a detailed device description and version/model, Issuing Agency, labeler company’s name, address and DUNS code. Additional information is also required per submission, including some of the following:

Commercial distribution – Determines when a record would be publicly available on AccessGUDID, whether the device is in commercial distribution, and when the device is no longer offered for commercial distribution by the labeler on record.
Alternative or additional identifiers – Indicates if the device is exempt from Direct Marking (DM) requirements under 21 CFR 801.45, if the DM DI Number is different than the Primary DI Number and what the secondary DI, previous DI, or package DI is.
Customer contact – Phone and email address of a customer service contact is required so patients and consumers can ask any device-related questions.
Premarket – Determines if the device is exempt from premarket submission or the FDA premarket submission number.
FDA product code and listing – Both the FDA product code (a categorization for devices) and Product Code Name (associated with the three-letter Product Code) are required in addition to the listing number, which is assigned by FDA during registration and listing of all devices in commercial distribution, regardless of pre-market authorization requirements.
Storage, handling and sterilization – Identifies device storage and handling requirements (such as temperature) and sterilization specifications including, packaged as sterile or requires sterilization prior to use.

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Preparing for Submission to GUDID

A critical prerequisite step for submitting device data to the FDA begins with establishing a GUDID account. To do so you will need to decide how many GUDID accounts are needed. Each account is tied to a separate Labeler Organization, such as corporate headquarters. How large is the organizational structure? If it is small to medium-sized, usually only one account is necessary. What about larger companies? Bigger companies may request a single account for all products OR create multiple accounts for differing portfolio segments.

Both Labeler Organizations and Labelers must be sourced in the account application with their Dun & Bradstreet DUNS number. Note, while application for a DUNS number is free, the process may take up to 30 business days.

How to Submit

Organizations must determine how they want to submit data through one of two methods: manual data entry or Health Level 7 (HL7) Structured Product Labeling (SPL). Some considerations include:

Does the company have a small number of records to submit? If so, they may want to enter data into the database manually through the free web interface, although the cost of staff time and expertise needed to enter and validate data should be considered regardless of device amount.

Does the company have a high volume of submissions? If so, they will likely need to submit data in an SPL format, requiring data conversion for submission-ready SPL files (through the FDA Electronic Submissions Gateway (ESG)). In this case, companies can purchase/build software or work with third-party providers, such as Reed Tech, for expertise in both validating and submitting data.

GUDID Web Application Overview	HL7 SPL File Submission Overview
Ideal method for fewer records needed for GUDID submission	Ideal method for several records needed for GUDID submission
Requires manual data entry	Allows bulk submission and requires technical knowledge

Once companies determine their submission method, they must identify GUDID account personnel and request a GUDID account from the FDA. If they want to submit data in an SPL format, the SPL submissions need to be tested (in a separate test account provided by FDA) to ensure submissions flowing through the ESG are successfully imported.

Are You Affected by the Class I Deadline?

Class I and unclassified medical devices required to be labeled with a UDI code must submit product data to the FDA GUDID by September 24, 2022. Medical device companies must first determine if their products are affected by this deadline. Do any of the following conditions apply to you?

Class I device is distributed to professional healthcare facilities (hospitals, clinics, physician offices, etc.)
Class I device is intended only for use by healthcare professionals
Class I device is reused on different patients and reprocessed using high-level disinfection and/or sterilization
Class I device requires 510(k)

Note there is a Class I GUDID Submission Exception for certain Class I devices that are 510(k) exempt and only sold over the counter to consumers.

Some examples for product types requiring UDI in a professional use, such as a hospital, include hospital beds, stethoscopes, dental instruments and equipment (chairs). Certain consumer use products (such as sunglasses, pill crushers, electronic toothbrushes) require UDI but not GUDID submission. Products sold in both professional settings and over the counter require UDI and include items such as band aids, first aid kids, and dental floss.

Upon determining if a product falls within the Class I submission regulation, FDA compliance for Class I devices includes:

Labeling – The UDI must be on the device product and package labels in a human-readable plain-text and Automatic Id and Data Capture (AIDC) technology, with the date format listing in YYYY-MM-DD (except AIDC date must use Issuing Agency date format)
Direct marking – Multiple use or reprocessed devices must have the UDI permanently marked
Submission to GUIDID – DI & device attributes (57 total) must be submitted to GUDID (through public portal, AccessGUDID)
Reporting and retention – UDI must be included in Annual Reports, DHR, complaints, MDR, recalls, service, tracking, post market surveillance, in addition to electronic record compliance (as part of 21 CFR 11) and a 3-year record retention (even after device is off of the market)

How to Comply with US FDA Class I, GUDID Requirements

A common question I hear from our customers, especially those with Class I medical device products, is “where do we begin?” Here is an implementation summary for you to reference as the Class I submission deadline quickly approaches:

UDI process prep – Determine who in your organization is responsible for UDI submissions and create a UDI governance team. Also identify FDA UDI requirements for your products, evaluate your situation and prepare the UDI environment.

Data prep – Understand what data elements are required, collect source GUDID data as well as normalize and validate data. If needed, you can work with a vendor, such as Reed Tech, to help with this step.

GUDID system and submission – Evaluate, select, and implement a GUDID solution, create FDA GUDID & ESG accounts, submit GUDID data to FDA and verify GUDID submission and publication.

Labeling system – Prepare labeling environment and test labels.

UDI operation – Start production and maintain data and systems, in addition to preparing for international UDI requirements for various health authorities around the globe.

Business

Customer Service Outsourcing: Enhancing Efficiency and Scalability

Published

2 months ago

October 19, 2023

Irfan Younas

In today’s fast-paced business environment, companies are constantly striving to enhance operational efficiency, cut costs, and deliver unrivaled customer experience. One strategy that is gaining traction across numerous industries is customer service outsourcing. For businesses that aim to scale without compromising the quality of their customer support, outsourcing emerges as an attractive proposition https://outsourceit.today/navigating-customer-service-outsourcing/ is the perfect guide to navigate the customer service outsourcing space.

Table of Contents

Understanding Customer Service Outsourcing

Customer service outsourcing involves contracting third-party companies, known as Business Process Outsourcing (BPO) providers, to manage various customer service functions. These can range from answering customer inquiries and processing orders to managing complaints and providing technical support. Instead of maintaining an in-house team, businesses allocate these responsibilities to experts in the field.

Benefits of Outsourced Customer Support

Cost-Effectiveness: Maintaining an in-house customer service department can be costly due to recruitment, training, infrastructure, and overhead expenses. Outsourcing often results in significant savings as businesses only pay for the services they require.
Scalability: Outsourcing enables companies to easily scale their customer service operations according to demand. During peak seasons or promotional events, they can ramp up services without the hassles of hiring temporary staff.
Expertise: Reputable BPO providers specialize in delivering top-notch customer service. They are equipped with the latest technology, trained professionals, and up-to-date industry best practices, ensuring customers receive an exemplary support experience.
24/7 Support: Global markets require round-the-clock support. Outsourcing allows companies to offer 24/7 customer service without the logistical nightmares associated with time zones and shift management.
Diversified Skill Set: Different customer queries require various skill sets. Outsourcing partners often have diverse teams with specialized skills, ensuring that every customer query, from technical issues to general inquiries, is addressed by the right expert.
Focus on Core Business Operations: By offloading customer service responsibilities, businesses can redirect their resources and focus on their core competencies, product development, and market expansion.

Challenges to Consider

While there are numerous advantages, it’s also essential to address potential challenges:

Cultural Differences: Companies need to ensure that the outsourcing partner understands and aligns with their brand’s values and voice. Cultural differences can sometimes lead to misunderstandings or miscommunications.
Quality Control: Outsourcing involves relinquishing some control over the customer service process. It’s vital to establish regular checks and performance metrics to ensure the outsourced team meets the desired quality standards.
Data Security: Sharing customer data with third parties requires rigorous data protection measures. Companies must vet BPO providers to ensure they comply with global data protection regulations.

The Future of Customer Service Outsourcing

As technology continues to evolve, the outsourcing landscape will transform alongside it. Artificial intelligence, machine learning, and advanced analytics will play pivotal roles in making outsourced customer support even more efficient, predictive, and personalized.

Outsourced customer support is no longer a mere cost-saving tactic; it’s a strategic move that offers businesses agility, expertise, and scalability. By partnering with the right BPO provider and maintaining a keen focus on quality and customer satisfaction, businesses can leverage the many benefits of outsourcing and set themselves apart in an increasingly competitive marketplace.

Business

How to Choose the Cheapest Shipping Service for Your Business

Published

2 months ago

September 28, 2023

Wnweekly

There are many shipping services to choose from, but how do you know which one is the cheapest?

First of all, it’s important to know what shipping service you need. This will help you narrow down your options. If you need a fast delivery, for example, then a courier might not be the best option for your business. If you want to ship items in bulk and have them delivered at once, then a trucking company might be the best option for your business. Once you know what type of shipping service you need, it’s time to start looking into prices.

First thing first: there are three main factors that determine how much an item is going to cost when shipped:

1) weight

2) distance

3) method of shipment

The Importance of Choosing a Low-Cost Shipping Service

When it comes to shipping, the cost of the service is often one of the most important factors that an ecommerce company should consider.

Shipping is a big part of any ecommerce business. The cost of shipping can make or break a company if they don’t find a low-cost shipping service to work with.

Many companies choose to use services for their shipping needs because they are considered more reliable and offer more delivery options than other low-cost services. However, companies who don’t have these resources can still find affordable options for their shipping needs with some research and effort.

How to Find a Low-Cost Shipping Provider

Shipping is a major cost for many companies. It is not always easy to find the cheap shipping company. However, there are some ways to find one.

First, you can compare prices on your own by searching on Google and Amazon. You can also use the comparison sites like Shippo or Shipwire to get quotes from multiple shipping companies and then choose the best one for you.

What are the Benefits of Using a Low Cost Shipping Provider?

The benefits of using a low-cost shipping provider include the following:

It is cheaper for the customer and easier for the business to manage their logistics.
It helps in reducing the carbon footprint and saving money on fuel costs.
It helps companies save time and money by not having to pay for expensive logistics services that are not needed anymore.
The company can reduce its carbon footprint by selling more products online and also have a higher profit margin than before due to lower overhead costs related to shipping, warehousing, and inventory management

What Are the Drawbacks of Using a Cheap Carrier?

The most important thing to remember is that cheap carriers are not always good for your wallet.

When you use a cheap carrier, you sacrifice quality and reliability. They don’t have the same features as other carriers like phone support or data coverage. They also cost less which means they have less features and a smaller selection of phones.

Cheap carriers are also harder to sell because they have fewer phones to offer. It’s hard to convince someone to buy a phone when there are so few options available.

Conclusion: Which is the Cheapest Way to Ship Your Goods?

There are many ways to ship your goods, but the cheapest way to ship your goods is by using the United States Postal Service. It is also the most reliable and has a good reputation.

Business

How to set up a successful Twitter promotion campaign

Published

2 months ago

September 28, 2023

Wnweekly

How to set up a successful Twitter promotion campaign

While newer structures like TikTok are making a touch across social developments, Twitter dominates as a hub for energetic conversations. In reality, it nevertheless sees a 29% 12 months-over-12 months increase in monetizable everyday active customers. This amounts to over 187 million daily lively bills that could see ads on the platform.

Brands should pay attention to Twitter while allocating their social advertising and marketing price range.

Still on the fence about how to use Twitter commercials for your logo? Or, you’re searching comprar seguidores twitter out pointers to attain the following level of success along with your approach. In this manual, we explain how to promote it on Twitter, what a fantastic advert looks like, and how to bag more returns on your campaigns.

Now permit’s have commenced.

Why Twitter ads deserve your interest

Twitter marketing has several potentials in terms of reach and engagement. The platform has made numerous adjustments within the shape of advanced concentration on new ad codecs and full attribution. This allows advertisers to get more out of their Twitter advert campaigns.

The evidence is in the numbers:

Ad engagement is up 35%, even as the fee in step with the arrangement is down by three%.
Click-thru price over single-asset ads elevated by 15% for internet site carousel ads.
Attributed website visits are up 10X due to the brand-new Twitter Click ID.
It’s perfect for reaching 30-forty nine-12 months-olds as this age group makes up 44% of the Twitter demographic.

Types of Twitter advertisements in motion

Twitter offers numerous picks in advert kinds. However, to run a successful advertising campaign on the platform, you must decide which alternatives will assist you in achieving your dreams.

Promoted Accounts and Follower Ads

This lets you promote a whole Twitter account in place of a particular Tweet. It helps you target users who might be interested in your brand but still need to follow you. So it’s an appropriate advert if you need to develop your Twitter following. With this form of Twitter advert, your account will appear inside the “Who to follow” segment of a consumer’s feed.

Promoted Tweets

These are everyday Tweets promoted via paid advertising to attain a bigger target market. Encouraged Tweets display in numerous locations, which include seeking effects, user profiles and timelines.

Promoted Trends

This permits you to promote your brand’s trending topic and appeal to the right target market. Your Promoted Trend will display prominently on the top of the “Trends for you” phase. Comprar seguidores Twitter instantaneamente

How to install an ad campaign on Twitter

If you’re acquainted with setting up Facebook ads, you don’t have trouble launching a Twitter advert campaign. But if you’re new to the scene, we’ve included you. So before you begin, make sure you install your Twitter commercials account.

Register on your Twitter account and go to the Twitter ads onboarding web page. Choose some time sector and the United States, and that’s it. Next, comply with the steps to create your Twitter advert campaign.

Choose your ad objective

What do you need to get out of your advertisements? Depending on your ad objective, Twitter will provide excellent engagement kinds and moves to your campaign.

Reach: This goal shows your advert to as many humans as viable within a fixed time frame. And you only pay for each 1,000 Tweet impressions. Use this to raise emblem consciousness and enhance emblem belief.
Video views: Get more ideas in your motion pictures and GIFs with video views campaigns. Use this to power emblem consciousness and viewer engagement.
Pre-roll perspectives: Display your advertisements at the beginning of a video (just like on YouTube). This gets your brand in front of a larger target audience, supporting you to enhance your attention.
App installs – Get more downloads in your app. This provides an “Install” button to your commercials.
Website clicks: Get more human beings to visit your website after seeing your ad. This type of marketing campaign additionally leverages Twitter’s Click ID to offer you a reliable manner to degree visits coming out of your Twitter advert.
Engagements: Drive more conversations around your emblem by designing ads that humans would want to interact with.
Followers – Promote your Twitter account and appeal to extra followers.
App re-engagement: Encourage human beings to open or take a particular motion on your app. Use this to keep your app top of mind, decorate emblem loyalty and pressure in-app conversions.

Fill out your marketing campaign information

The subsequent page allows you to feature more records about your marketing campaign. Here, you could name your campaign, set a budget and decide on a time frame.

Create ad businesses

Next, you could start constructing advert companies. Ad organizations roll up underneath a marketing campaign and may be used to split out details like budget, targeting, and creatives so you may be granular along with your goals and creative checking out.

For the primary campaign, it’s satisfactory to begin with, one advert institution. After that, you can experiment with extraordinary ad agencies as you get comfier with Twitter advertising. melhor site para comprar seguidores twitter

Click on the drop-down menu beneath “Ad Groups” in the left-hand corner of the display screen. Then pick out the option to feature your advert group details. Next, name the ad organization and select your aim and bid approach.

For your first campaign, the “Autobid” alternative makes the most experience as it automatically maximizes your results at the lowest charge.

Choose your target audience

Which type of target market do you need to target for this ad organization? Twitter shall decide on a particular audience for each advert institution.

For starters, you could pick the age range, gender, area and language of the human beings you want to target. Other options include matching your target market based on the devices they use.

For instance, you can target the most influential Apple device customers for one ad institution and the best Samsung users for every other. And when you have current custom audiences, you can consist of or exclude them from this ad group.

Twitter also comes with concentrated solid functions to personalize your ad group. This lets you target audiences based on the key phrases they’ve searched. And it’s much less challenging to reach relatively applicable customers based on their hobbies and communique topics. You may even target humans based on the movies and TV shows they watch.

To reach folks interested in your brand, you may even pick target follower look-alikes. This lets you attain people who share identical pursuits as the followers of an account. This is a neat way to discover a new and especially relevant target market institution that stocks similar traits, for example, your account’s current follower base.

Choose your ad placements and creatives

Next, decide where your ads need to appear inside the one-of-a-kind areas of Twitter. After this, you’ll pick the advert innovative you want to sell. Twitter can also give you specific options depending on your campaign objective.

For instance, it may ask you to pick out a published Tweet or a video for upbeat commercials. On the other hand, Follower campaigns will only need innovative advertising, considering they promote the account.

Now you’re ready to launch your Twitter ad campaign. To make sure you get the most out of your Twitter ad finances, read on for a few pleasant practices to create desirable ads.

Twitter advertising exceptional practices

Want to get more from your Twitter ads? Follow these high-quality practices and examples from top brands. Comprar seguidores Twitter 2022

Stick to your brand voice

Keep a regular brand voice to ensure your commercials resonate with your audience. Your promoted content needs to be unique from your organic ones in phrases or ways you speak.

For instance, it has a sturdy logo persona on Twitter, with humour being the essence of its emblem voice. It ran a video perspectives ad on the platform to unfold recognition for Testicular Cancer Awareness Month. Even though the topic was extreme, the logo still determined a way to add a comedic twist to the video and preserve its signature brand voice.

Write a short and tasty replica

Twitter customers quickly flow from one Tweet to the subsequent. So stay far away from substantial textual content blocks. Make positive your reproduction is short and to the factor. Just because there’s room for 280 characters doesn’t suggest you need to dissipate all that area.

If it fits your logo personality and you don’t overdo it (accessibility attention for those who use screen readers), don’t forget to use emojis to capture attention. Your reproduction ought to be short enough to hold users engaged but not so fast that it’s meaningless.

Use brilliant visuals

Eye-catching videos and pix can make your ad stand out and stop the scroll, driving more engagement with your ad. They could make human beings forestall scrolling and interact with your advert. So make sure to apply excellent visuals that speak for the first-rate of your merchandise/services.

Have a clear call to movement

Let humans realize what you need them to do after seeing your advert. Whether you go to your website or download your app–your advertisements must have a CTA that sincerely mentions the following step. Comprar seguidores Twitter barato

Learn about your overall organic performance

How humans respond to your natural Tweets can tell you how to run your Twitter commercials. First, find out what content material receives the most engagement and effective sentiment from your target market. Then use those insights to inform your advertising and marketing decisions.

Test and optimize

Of course, the unique way to ensure your advertisements are running is to check them—Run A/B checks on distinctive advert placements, messaging, layout, and more. Then use the statistics and insights to create fairly optimized advertisements so that they will rake in earnings.

Ready to hit the ground jogging with Twitter advertisements?

With full attribution and better concentration, Twitter is continuously evolving to serve brands. And with the proper method, it can be a valuable advertising channel for your commercial enterprise.

But the quick-paced nature of the platform additionally means you have to take extra care on what forms of advertisements you run. If you need assistance getting started, download our guide on creating an overall social media strategy.