Medical Devices

Industries | Medical Devices

The Internet of Things (IoT) is revolutionising the medical device industry with a huge increase in wirelessly connected medical devices leading to improved patient monitoring and real time access to patient data.

The introduction of IoT to the medical device industry comes at a challenging time as there is a push from governments and healthcare insurers to control costs. In this environment, more and more medical device companies are looking to their outsourcing partners to provide innovative solutions whilst reducing costs to the customer.

M&M Qualtech has over thirty years’ experience working with non-invasive medical devices, such as diagnostic equipment, monitoring devices & respiratory devices. Our industry experience and our engineering capabilities allow us to quickly understand our customer’s requirements, developing into an integral part of our clients manufacturing team. We understand the challenges that are faced by medical device companies today and work with our clients to provide innovative, cost effective solutions allowing our customers to compete in the medical device industry.

Why Choose M&M Qualtech?

1. Accelerate Route to Market

First to market has immense value in the medical device industry. M&M Qualtech have over thirty years’ experience bringing medical devices from concept to the consumer, quickly. Having a knowledge partner such as M&M Qualtech allows you to get your medical device to market faster, facilitating a faster return on investment.

2. Optimise Design

Due to the safety critical nature of the medical device industry, there are many risks at play. M&M Qualtech will advise you on the optimum design for functionality, manufacturing and risk. In recent years supply of particular commodities, materials and components has been affected by various influences be they natural, economic or political. We will be able to offer advice on how to mitigate these risks in the supply chain by evaluating multiple sources and solutions while balancing design and functionality. It is critical that these are considered as early as possible in anticipation of the regulatory pathway of your medical device.

3. Varied Experience

At M&M Qualtech we have experience working with medical device customers of various sizes from start up technology companies to large multinationals. This mix of experience ensures that we will understand the challenges faced by your specific business, no matter what stage your business is at, and can support you as grow and as your needs evolve.

Aerogen, who is now the world leader in the design and manufacture of high-performance aerosol drug delivery technology for hospitals and technology, was supported by M&M Qualtech’s incubator program and we remain their manufacturing partner today.

4. Responsive Supply Chain

We have the capabilities to change production demand as our client’s business demands ramps up or down.

5. Regulatory Requirements

When you work with M&M Qualtech, you have the security that we can stand up to the rigour and scrutiny of medical device regulation and auditing standards. We are FDA registered and are certified to EN ISO 13485-2012 and EN ISO 9001:2015.

6. Located in Medical Device Hub

M&M Qualtech is located in Galway, Ireland, which is an established medical technology cluster. 9 of the World’s top 10 medical technology companies are located in the region.

7. On Site Class 8 Clean Rooms

Testimonials

  • “The guys at Qualtech were an excellent team to deal with at each stage of the design process from initial product concept through to housing the finished product. While working with the team at Qualtech their vast experience in product development was apparent and greatly helped us to streamline and accelerate our product development.”

    Dr. Gavin Corley CTO Bluedrop Medical
  • “M&M Qualtech’s experience in the regulated manufacturing environment is invaluable to us as a start-up company in the medical device arena. M&M Qualtech have also been able to contribute to the design advancement, including design for manufacture of our various hardware designs over the years”

    Cosmin Rotariu SyncroPhi Systems Ltd

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to discuss how we can get your innovative device to market quickly