May 17, 2020

Money making diet plans: Rapid waste of money

money making diet programs
balanced diet
fitness centers
4 min
The important part of healthy living is a balanced diet. Dieting is a practice of eating food in a regulated fashion to achieve and maintain a controll...

The important part of healthy living is a balanced diet. Dieting is a practice of eating food in a regulated fashion to achieve and maintain a controlled weight. Nowadays, we find so many diet programs endorsed by celebrities and fitness experts claiming instant weight loss. You might have seen health and fitness centers placing advertisements in newspapers, Loose 10 kgs in a month.  This is nothing but just a money making business for companies who advertise such diet or supplements programs.  These diet programs promise results which will not take place immediately. Their goal is to not to shed weight or make you healthy, but mint money and gain recognition.

How to select your diet plan?

While choosing a diet plan, there are many factors that one needs to consider. A healthy diet helps in maintaining and improving general health.  Healthy diet needs to have a balance of proteins, fats, carbohydrates, calories to support energy need and the micronutrients needed to meet the needs for human nutrition.  So, let’s consider certain factors that will help in selecting the diet plan.

  • Simplify:  Do not be concerned about your diet in terms of counting calories or measuring the portion sizes.  Think of your diet in terms of freshness, color and variety. This way it will help in making healthy choices. Find foods you like and easy recipes that have fresh ingredients.
  • Consider nutritional needs:  Consider nutritional needs. The teenagers, children and elders have dietary needs and they require special diets. The nutritional needs vary with gender, size, age, lifestyle habits, health and occupation.
  • Look at the budget:  Take a look at the budget. One does not need to spend a lot of money to have a nutritious and tasty meal.
  • Listen to your body:  Ask your body if you are really hungry or have water to see if you are thirsty instead of hungry.  If you feel full, then you should stop eating. It takes only a few minutes for your brain to tell your body that it had enough food, so eat slowly.
  • Exercise:  To plan a healthy diet, exercising is very important.  It will help in burning fat, make you feel healthier.
  • Ask your siblings and friends: Ask your friends and siblings whether they are on a diet and what are the activities in which they are involved are. You can also learn a lot from them.

Rapid diet programs are not successful

People   who are very healthy and obese are always on look out for shedding instant weight.  So, they are most likely to get influenced by such rapid diet programs which will most likely not happen.  Say for example,   a popular international celebrity endorses a popular diet program.  The program uses her to gain publicity and make people believe that they can also achieve size zero figure like their popular celeb which is a very rare phenomenon. There are others fitness centers who are in the race to promote their services they offer through print advertisements and also through TV.  Rapid weight loss is a bad one. Changing your lifestyle and slowly losing weight is the best way to shed weight. If you follow a rapid diet program, then you will surely end up putting more weight that you have lost after you have stopped using the program.

Modify your lifestyle for better living

An individual can shed weight and keep it under control by making healthy lifestyle changes of eating and exercising better. It will also boost your confidence level as you would be shedding weight and it will be maintained and show you positive results. But, a quick method of weight loss will only end up in you losing your self-worth and you will eventually gain your weight back.  So what one needs a good diet program that helps one in relating to food,  how to pick a portion size, how to tell what’s  good , and when one needs to stop eating, even if he or she still has food in her plate.  Holistic health comes from a healthy relationship with food and understanding our own bodies.  

So, the lesson we learn is to simply avoid following these diet programs which only aim to shell out money from your pocket, and instead focus on diets which ensure you the benefit of losing weight and a long-term lifestyle change, which will be a positive change.

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Jul 24, 2021

A guide to labelling compliance for medical devices

Susan Gosnell
4 min
A guide to labelling compliance for medical devices
Susan Gosnell, Product Manager at Loftware, explains labelling compliance for small medical device manufacturers

Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.

Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.

But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it. 

On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.

Putting a plan in place

MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.

Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance.  They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.

When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.

Why labelling in the cloud offers a roadmap forward

Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.

The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.

When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.

A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.  

Future-proof technology

The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.

While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.

Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.

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