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Six Things Some Medical Device Manufacturers Have to Do to Place a Product on the Market

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Developing a new product is never easy. Obviously, it all depends on what industry you belong to, and what kind of product you are trying to sell.

In the medical device industry, the product development process is governed by a lot of regulatory requirements. This is true for quite a few industries, but the medical device industry is characterised by the manufacturers being audited continuously by regulatory bodies or organisations that have been designated to audit manufacturers.

Areas that are particularly emphasised in the medical device industry are design control, risk management, and post-market surveillance.

Here are six important requirements for medical device manufacturers to observe.

1. Have a playbook or a QMS

As simple as it might seem, a playbook for the product development process is essential. But for companies working with more formalised product development, it is usually not referred to as playbook, but rather a QMS, which is short for Quality Management System. As the name suggests, the QMS is focused on the quality of the products of the company, and it comprises procedures for the processes of the company.

Medical device companies are required to have about 30 documented procedures according to the quality management standard ISO 13485 and then a handful more according to the Medical Device Regulation and Quality System Regulation.

2. Verify the effectiveness of training

A general requirement in most industries is to provide employees with the training they need to perform their jobs. In the medical device industry, this is also a requirement. But in addition to training people, medical device manufacturers are required to verify the effect of training actions taken.

Verifying the effectiveness of training is easier said than done, but it can be done by using quizzes or practical tests.

3. Implement corrective actions

Mistakes happen. A lot of companies will try to correct mistakes, and that is all good. But for medical device companies the requirement is to also prevent making the same mistake again. This, of course, makes perfect sense. But strong corrective actions can be hard to identify and implement.

4. Collect and process any complaints submitted

Not listening to feedback is not a smart move, especially because the very purpose of feedback is to present us with a point of view different from ours, or with first-hand experience from a user. The same goes for complaints.

In the medical device industry, everyone should be trained to recognise when they come across a complaint. And complaints should be recorded and investigated. Complaint statistics would also be included in the data analysis process and brought to management’s attention during management review. All of this is required.

5. Verify all changes to products and software 

When you implement changes to the product or its software (if included), you will need to verify that the product still meets the design inputs or product requirements. This should include the impact the change has on the safety of the device as well as the usability of the device.

6. Invest in usability engineering

Most companies will strive to make products with a great user experience and invest in usability. In the medical device industry, the usability has a slightly different purpose. It is to ensure that the product is safe from a usability point-of-view. This includes showing that users understand the instructions for use and other information provided to them.

This is important in every industry, but when it comes to the medical device industry, this is, in most cases, essential, simply because a single misunderstood instruction can lead to injury or even death.

Which of these principles do you adhere to in your industry?

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Polonez America: How to Prepare a Car for Shipping to Poland?

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Polonez America is the largest shipping company in the US, focusing on commercial and personal transactions from the US to Poland and 42 other countries.

With over four decades of industry leadership, it (https://www.polonezamerica.com/en/vehicles) has been known for reliable services and good quality work by its customers. 

It offers a holistic suite of shipping solutions such as container rentals, personal shipments, commercial cargo, and vehicle shipments by air or ocean to achieve a seamless experience for their clients during shipment.

Why Vehicle Preparation Matters

So, how to prepare for shipping a car to Poland? Before going through the customs clearance, some procedures must be done. Let’s take a look at the quick guide!

  • Empty tank: Full fuel tanks lead to leakages and fumes, thereby increasing safety risks when shipping vehicles. By emptying the gas tank before shipping your car, you will eliminate these dangers, making it safer in transit.
  • Unplugged battery: When left plugged in while being shipped, the battery may lose charge, making one’s vehicle unworkable upon arrival. Unplug it so that you can save the energy level of your battery, avoiding problems associated with starting, which leads to smooth driving immediately after getting there.
  • Isolating battery cables: Accidental touching between battery cables during transport may cause short circuits, thus damaging your vehicle’s electrical system. This danger can be mitigated by isolating the wires leading to your car’s electrical components remaining undisturbed in its course of transportation.

Additional Information

  • Vehicle inspection: A thorough inspection should be conducted, noting any pre-existing damages to facilitate accountability or even help file an insurance claim should anything happen unexpectedly while in transit. All the documents must be at the ready. 
  • Personal belongings: To avoid causing any loss or damage during transit, ensure that no personal items are left inside your vehicle in accordance with shipping regulations.

By following these car preparation instructions it not only ensures car protection while moving but also assists in achieving a smoother and more efficient shipping process overall.

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The Importance of Leadership in a Business

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If you have a business, you already know how competitive it can be, and if you have a flock of sheep but no shepherd to gently guide them in the direction, you are asking for trouble at worst, or a loss at best.

Having a team that doesn’t know what they are doing is not only a waste of everyone’s time but also a waste of resources. Leadership is essential in creating a bridge between the work that needs to be done, and the team members that are ready to do it.

Because of this, there are many ways in which leadership is an important component of a business.

These are some of the key reasons why leadership is important for a business and why this important factor shouldn’t be slept on!

Leaders Help Develop Employees

The employees that are there and ready to take your business to the next level are great – you already know that, you hired them! As they learn more about the business, and establish a position there, you might find that some are ready to go further.

A good leader can spot when an employee shows interest or skill in either their own or another area of the business, when they might be ready to take on more responsibility, or just when the potential is being wasted.

Leaders should be ready and willing to help employees develop to their highest potential within the business, as it benefits everyone involved. You can expect an increase in confidence and trust from your employees when you treat them as individuals, working on their strengths and not catastrophizing their weaknesses.

Leaders Make Critical Decisions

A leader is at the front guiding everyone towards a goal – they also have to make the critical decisions and judgments that will benefit the wellbeing of the business while keeping employees at the forefront of their minds.

In this role, a leader should be able to look at the “big picture” and make logically calculated decisions for the best outcome. This doesn’t mean it will always be an easy decision to make, but they are entrusted with the wellbeing of the business (which includes the employees), and their decisions should reflect that.

If you are someone who believes they can make a real difference to businesses they believe in, and lead a team in a way that fosters growth for all involved, then take a look at what careers in leadership are available for you. The world needs kind and compassionate leaders who can focus on the health of a business and take care of their employees.

Leaders Boost Morale

Do not underestimate the damage that a team under pressure, underappreciated, and overworked can do to a business.

It is seen far too often in workplaces where employees have been piled with work, or their contributions have gone unnoticed (at least to them), and they are struggling to be motivated towards the collective goal. 

A minimum wage isn’t enough to motivate employees to do their best work anymore, especially when it doesn’t even cover the cost of living.

Leaders need to provide a space where employees feel appreciated heard, and where it is clear that what they do matters – otherwise, they can easily be overworked and underappreciated somewhere else. That is when you will realize an excellent employee has slipped away too little too late.

Leaders Understand Individual Needs

Employees are human, with different skills, needs, wants, goals, and pain points. A leader knows this and will work with them so they are able to bring their best self to work.

Neurodivergent employees might need to ask more questions to gain a deep understanding of what they are doing, some employees might need to take regular breaks rather than an hour slot.

You might find even that some team members work best when they can work from home. Leaders know that not a one-size-fits-all approach will get the best out of their team and are happy to work with them to achieve that.

While a robot empire doesn’t seem to be a sci-fi film premise anymore, nurturing human development within a business will give you much more back than artificial intelligence can.

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5 Top Shopify Apps To Boost Your Store

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In this article, we’ll discuss Top 5 ecommerce apps are B2B, which help online businesses more easily serve their customers. Check out our list:

1. GPTMediaBuyer

GPTMediaBuyer: Your Smart AI Assistant for Google and Facebook Ads.

It can help you create and manage Google Ads and Facebook Ads (Meta) campaigns. It’s easy to use—just a few clicks, and you’re good to go.

It takes into account over 20 different factors about your store, including your audience demographics and location. It uses this information to create a media strategy that’s tailored to your business.

And it is not just smart—it’s also budget-friendly. It can potentially reduce your ad spend by up to 24%.

2. Shopify Flow

Simplify your e-commerce hustle with Shopify Flow, the ultimate tool for Shopify Advanced or Shopify Plus users. Say goodbye to manual tasks and hello to automated workflows, campaigns, and more—all within your store and apps.

From managing inventory to boosting customer loyalty, Shopify Flow is your all-in-one assistant for a smoother business ride.

3. Pirate Ship

Ahoy, matey! Say farewell to shipping woes with Pirate Ship, the treasure chest of savings for your online business. It’s free to board, and you only pay for shipping—no sneaky monthly fees here! With exclusive deals from USPS and UPS, you’ll sail smoothly toward higher profits, leaving shipping headaches in your wake.

4. SEO: Image Optimizer Page Speed

Boost your online visibility with SEO: Image Optimizer Page Speed, the secret weapon for turbocharging your e-commerce site. From faster loading speeds to top-notch search engine rankings, this tool does it all.

With features like image optimization and SEO analysis, it’s your ticket to higher conversions and happier customers. Choose from a free plan, a free 3-day trial, or dive into the full experience for just $34 per month.

5. Quickbooks Online Global

Take your global business to new heights with Quickbooks Online Global, the ultimate wingman for Shopify sellers beyond US borders. Sync up your Shopify store with Quickbooks Online International for hassle-free bookkeeping and more.

From tracking income to automating invoices, this tool does the heavy lifting so you can focus on growing your business. Sign up for a free plan or explore tiered pricing starting at just $30 per month.

Hope that our Top 5 Shopify Apps was useful to you. Supercharge your Shopify store!

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