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New EU Devices Regulations deficient as a safety and effectiveness check, says German study

[urlpreviewbox url=”http://mdi-europa.com/new-eu-devices-regulations-deficient-as-a-safety-and-effectiveness-check-says-german-study/”/]

GA2 Medical shares a useful link about the new EU device regulations.

Visit our website www.ga2medical.com to find out more about our range of single patient use and reusable medical devices and products.

TAKE ADVANTAGE OF WORKING WITH A COMPANY THAT TRULY LIVES BY ITS MOTTO – PERFORMANCE. BEYOND. EXPECTATIONS.

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6. Understanding our Clients ▾

The foundation of our existence is listening to you. We canvass your individual needs and rise to the challenge. We understand your needs by asking, listening and be inquisitive. With careful preparation and preliminary work, we find the most suitable solution for you. We are on top of things and we develop results. We use our knowledge and experience to identify and present the right products, services and solutions to meet your needs.

We canvass your individual objectives and needs and use them to bring out new philosophies, initiatives and ideas.

We truly believe that the best solutions are found via collaboration and open communication.

What this means to you – With fresh thinking, idea generation and initiatives, we develop the best possible service and product selection for you and your customers.

TAKE ADVANTAGE OF WORKING WITH A COMPANY THAT TRULY LIVES BY ITS MOTTO – PERFORMANCE. BEYOND. EXPECTATIONS.

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5. Safety ▾

The quality and origin of our raw materials, our production processes and the safety of our staff, clients and end users are out top priorities. Our operations go beyond simply complying with internationally recognized ISO 13485:2016 quality standard and CE marking. Through these activities, we ensure that we aren’t just ticking boxes, but we are doing the right things, as you demand and expect.

By meeting these standards, not only are we free to move and trade our products locally and internationally, including the European Economic Area, but we have committed to a quality management system that establishes and maintains the effectiveness of our processes, providing medical devices and related services that consistently meet customer and regulatory requirements. Ultimately, this gives you peace of mind that the traceability, design verification, materials validation, supplier controls, risk assessments, production control and delivery activities, for example, are an indispensable and integral part of our business.

What this means to you  Our first-class approach ensures consistently safe and high-quality products and service regardless of location.

TAKE ADVANTAGE OF WORKING WITH A COMPANY THAT TRULY LIVES BY ITS MOTTO – PERFORMANCE. BEYOND. EXPECTATIONS.

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4. Qualitative Continuity ▾

We challenge ourselves every day and hold our products to the highest quality standards. We pledge that our quality remains consistently the best throughout the industry, whilst maintaining a level of customer service that is the envy of our competitors.

We make good on our promise of the highest quality of product and service, because as a manufacturing company, we have supply partners too, and we want to go beyond meeting your expectations, as we like to be treated and serviced by our supply partners.

To pledge consistent quality, we regularly gather customer feedback on what we have done right and wrong and what we need to change.

What this means to you – WE DON’T PLAY GAMES!

We are committed to consistency of the highest level of product quality and customer service and support you will rave about. We create a positive experience to our clients each and every time we communicate, right from the start of our relationship.

TAKE ADVANTAGE OF WORKING WITH A COMPANY THAT TRULY LIVES BY ITS MOTTO – PERFORMANCE. BEYOND. EXPECTATIONS.

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3. Performance/Price Ratio ▾

Our costs are based on the approach with which we pledge to you the best possible product, service and support at the best possible price.

We utilise high-quality raw materials and components sourced from our long-term partners – leading international manufacturers and suppliers – to ensure the optimal quality, safety and usability of our products while maintaining a balanced price/performance ratio.

We continuously develop our operations. Efficiency brings savings and thanks to our creative thinking, we can add value to our products and services without incurring additional costs.

Our customer relationships are based on the agreed service level, the success of which we monitor and evaluate on a regular basis. This way, you will receive exactly the agreed level of service.

What this mean to you – We continuously think about ways to increase the value of our products and we always give you the highest quality service at the most affordable price.

TAKE ADVANTAGE OF WORKING WITH A COMPANY THAT TRULY LIVES BY ITS MOTTO – PERFORMANCE. BEYOND. EXPECTATIONS.

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2. Partner not Vendor ▾

BEING A PARTNER WITH OUR CLIENTS IS IN THE DNA OF GA2 MEDICAL.

Partnership means that we work together to create new possibilities for the future. We are willing to do what it takes to make the other party whole. We ask questions of you. We understand our company’s capabilities. We contribute substantial knowledge, expertise and resources as needed. We understand you and your market.

It’s a key contributor to our growth and to the growth of our clients. When business opportunities knock on your door, know that the GA2 Medical team is working beside you.

What that means to you – Be part of a tailored business relationship based on mutual trust, openness, and shared risk and reward that yields a competitive advantage. Our partnership will be a fluid, flexible relationship based on honesty and integrity leading to success.

TAKE ADVANTAGE OF WORKING WITH A COMPANY THAT TRULY LIVES BY ITS MOTTO – PERFORMANCE. BEYOND. EXPECTATIONS.

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1. Business Ethics ▾

Our business ethics are the underlying framework in which we do business, by adhering to generally accepted standards of ‘rightful’ behaviour. The standards we follow are developed internally by ourselves, the industry, trade associations and professional organizations in which we work. They go beyond our legal requirements and are, therefore, about our discretionary decisions and behavior, guided by our values.

Our moral and social principals guide the way we behave. They apply not only to how we interact with the world at large, but also to our one-on-one dealings with a single customer and between ourselves within GA2 Medical.

We are a Malaysian company with significant Australian ties. We hold a strong business ethos based on Australian business practices and ethics with the advantage of Malaysian manufacturing benefits of location and cost savings. We do not provide golden samples, meaning that we guarantee that you will see the same top quality of product from samples to mass production. We do not increase the price and decrease the quality over time or undertake any other underhanded tactics that we hear so much about from our competitors.

What this means to you – We hold the standards and moral principles to judge right and wrong. This is relevant both to the conduct of our individuals and to the conduct of our organization as a whole. It applies to any and all aspects of our business conduct, from boardroom strategies and how we treat our employees and suppliers, to sales techniques and accounting practices.

TAKE ADVANTAGE OF WORKING WITH A COMPANY THAT TRULY LIVES BY ITS MOTTO – PERFORMANCE. BEYOND. EXPECTATIONS.

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6 Benefits of Plastic Components in the Medical Industry

Healthcare providers are always looking for new and innovative ways to enhance the quality of care patients receive while cutting costs.

Reusable and antimicrobial plastic components are helping medical practitioners overcome adaptive challenges in the healthcare industry. These plastics are advantageous for a variety of reasons, including the benefits listed below.

1)      Fewer Infections

Antimicrobial plastic is helping stop the spread of diseases in hospitals all around the world. It can repel or even kill bacteria on surfaces that doctors and patients regularly touch, preventing infections. Antimicrobial plastics can even kill bacteria when surfaces aren’t cleaned on a regular basis. This innovative new technology is in its infancy but it has the potential to help medical professionals and patients stay healthy longer.

2)      New Medical Devices

Plastics are allowing engineers, doctors and other medical practitioners to develop new medical devices that improve patients’ lives. Whether it’s enhanced pacemakers, joint replacement devices, or stents, plastics are enhancing the quality of care patients receive. Also, plastics are being used to replace metal instruments and medical devices, because plastics can be molded into more intricate shapes and come with a lower cost of production. Plastic components are a viable alternative to metallic parts and devices that can wear out prematurely and cause patients discomfort or pain.

3)      Cost Savings

Sterile and re-usable plastics are saving various stakeholders in the medical industry money, from the manufacturers of medical devices all the way to patients in hospitals. Plastic devices are cheaper to produce and easier to replace.  The savings are benefiting everyone involved in the patient care cycle. This is especially true in the case of re-usable plastics, which have longer useful lives compared to single-use metal devices, or other medical products made from lesser materials.

4)      Environmental Protection

Sustainable medical practices are growing and re-usable plastics are keeping hazardous materials out of landfills, protecting the environment. Plastics are also keeping medical devices and instruments in service longer and, in some instances, are reducing the number of product failures attributable to corrosion. While metallic devices wear out due to friction and organics interfering with their functionality, plastics can withstand tough stresses and last longer, due to their structural integrity and malleability. This translates to a more eco-friendly approach to medicine.

5)      Increased Comfort & Safety

Some patients are allergic to metal medical devices, making it difficult for them to receive the proper treatment and care. For instance, sometimes the metal parts in hip replacement devices can result in skin agitation, allergic reactions and extreme pain and discomfort when attempting to walk. Sterile, hypo-allergenic plastics with strong structural integrity have the power to replace metal parts in hip replacement devices, making it possible for patients to undergo treatment and live healthier lives. 

6)      Better Containers

When it comes to preserving medications, specimens and other important materials, manufacturers and medical practitioners alike need strong, chemically inert containers.  Sterile plastics are replacing metal or glass containers, because many plastics are capable of resisting some of the most hazardous substances on earth. Also, plastics do not shatter like glass, which makes it generally safer for use with hazardous materials and important specimens. Plastics are also good for creating packaging and protective coatings, which can help preserve the integrity of other materials.

Plastic components are helping patients live healthier, happier lives, while passing along cost-savings to various stakeholders in the medical industry. As healthcare continues to evolve, so too will the applications of high-quality plastics in healthcare facilities.

Article Source: Craftech Industries

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4 Advantages of Plastic in Medical Devices

GA2 Medical is a highly trusted medical supplies manufacturer located in Malaysia. Our plastic hollowware range is sold internationally and offers compatibility, exceptional barrier properties and increased user safety. Our products are a low cost alternative to other similar products currently servicing the healthcare industry such as stainless steel. Our products are equally suited for all applications within hospitals, surgeries, nursing, aged care and custom procedure pack applications.

1. Less Infection.

With recent advancements in manufacturing polymer technologies and raw materials, patients have benefitted from plastics used for medical devices. The growing concern of MRSA (antibiotics are no longer effective) and other hospital-borne infections, optional high tech polymers and antimicrobial plastics have been created and used in devices that reduce the risk of infection to patients. These plastics can repel or even kill most bacteria, even on high-touch surfaces, preventing infections. Interestingly, antimicrobial plastics have an extremely high effectiveness of killing bacteria even when surfaces aren’t regularly cleaned.

2. Cost Savings

The uses of plastic in medical devices are benefiting everyone in the patient care cycle with significant cost savings. Plastic devices are cheaper to produce and easier to replace. In particular, the use of reusable plastics, offer a longer life span compared to single use metal devices, or other medical products made from lesser materials.

3. Safety and Comfort

Due to the cost savings, our plastic range offers increased user and patient safety through the single patient use process. This also eliminates the need for large amounts of time and labour to decontaminate used and soiled devices and ensuring they have been cleaned correctly. Our products are manufactured through the injection moulding process. This provides a more rigid and thicker product with increased puncture resistance compared to other inferior alternatives such as thermo formed or paper pulp.

Some patients are also allergic to metal medical devices, which provides difficulty to administer treatment and care. For instance metal components used in hip replacement devices can result in allergenic reactions, skin agitation, pain and discomfort. Sterile, hypoallergenic plastics with strong structural integrity have the ability to replace metal parts in hip replacement devices, making it possible for patients to undergo treatment and live healthier and more comfortable lives. 

4. Environmental Benefits

Better medical practices are continually advancing and reusable plastics are keeping hazardous materials out of landfills and protecting the environment. Plastics are also assisting by providing longer service life for medical devices and instruments, and in some instances they are reducing the number of product failures attributable to corrosion. While metallic devices wear out due friction and organics interfering with their functionality, plastics due to their structural integrity and malleability can withstand tough stresses and last longer. This offers a better approach to healthcare and environmental factors.