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Changes to the EU MDR and IVDR and the future of the Medical Device Industry

[urlpreviewbox url=”https://www.youtube.com/watch?v=2oCV_82Y28E”/]

GA2 Medical shares a useful video about the changes to the EU MDR and IVDR.

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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Are you aware of EU MDR/IVDR deadlines? Explanations include a few surprises

[urlpreviewbox url=”http://mdi-europa.com/are-you-aware-of-eu-mdrivdr-deadlines-explanations-include-a-few-surprises/”/]

GA2 Medical shares a useful link about the changes to the EU MDR and IVDR deadlines.

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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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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Make the Switch

When health care facilities switch from reusable to single-use medical devices, the benefits extend beyond protecting patients from HACs. To realize the value of disposable medical supplies, here are the top reasons to make the switch from reusable to single-use devices:

Improved Patient Safety

Disposable devices can alleviate surgeon and health care provider concerns over the cleanliness of their surgical tools. With reduced risk of cross-contamination and increased infection control, single-use devices can improve overall patient safety and quality of care.

Save Time

Disposable medical devices relieve medical staff from the responsibility of properly cleaning, disinfecting and sterilizing instruments through extensive reprocessing cycles. When they arrive at the health care facility, single-use devices are ready for immediate use. And because they are disposed of after one use, hospital and medical practice staff do not have to spend time on decontamination or sterilization like they do for reusable devices. Plus, single-use devices are easily traceable and can eliminate the time spent tracking and accounting for reusable instruments.

With minimal preparation or post-procedure work, health care facilities can easily adhere to scheduling and avoid mishaps in medical procedures. Ultimately, single-use devices can significantly increase the facility’s efficiency.

Cut Down on Costs

While the upfront price of disposable supplies may be higher than reusable ones, providers can see significant long-term benefits. For instance, the initial savings on reusable tools can be offset by the outgoings associated with cross-contamination and infection complications. Plus, single-use devices eliminate the ongoing costs of reprocessing, which includes decontamination supplies, machine maintenance, utility use and employee time. With so many elements, it can be difficult to calculate the true costs of sterilizing and tracking reusable devices. Alternatively, single-use tools can simplify this process for health care providers.

Essentially, disposable supplies provide the same quality as reusable devices without the cost of upkeep. Over time, providers will likely see improved bottom line numbers after making the switch to single-use tools.

Reduce Environmental Impact

According to Practice Greenhealth’s Sustainability Report1, hospitals in the U.S. create more than 4.67 million tons of waste every year. It’s easy to assume that disposable devices would contribute far more to this number than reusable devices, but the opposite is actually true. The utilities and disinfecting solutions used when reprocessing reusable devices result in a much higher environmental impact. Plus, providers may also have to consider transport to decontamination facilities and landfill disposal. With single-use devices, there is no waste from these extraneous steps.

There are plenty of arguments on either side. However, when you strip away the reactionary scare tactics and look at some of the common sense information available in the single-use versus reprocessed medical devices debate, the traditionally-accepted arguments for choosing to reprocess lose their luster compared to the benefits of single-use medical devices.2

Ask GA2 Medical about making the switch or visit our website www.ga2medical.com to find out more about our range of single patient use and reusable medical devices and products.

References

1 https://practicegreenhealth.org/tools-resources/sustainability-benchmark-report-0

2 https://obpmedical.com/resource-center/blog/environmental-impact-single-use-vs-reusable/