Medical Devices

Industries | Medical Devices

Turn your Medical Innovation from a Vision into a Commercial Reality

Qualtech is a full service product lifecycle partner to the medical device industry. We support product development and manufacturing of your electronic device or component from concept right through the supply chain to end user. We perform in house testing, incorporate Design for Excellence (DfX) and have extensive manufacturing knowledge.

Our focus is making sure that your device is designed optimally, certified and ready for volume manufacturing to assure cost effectiveness and speed to market.

Our expertise is in electronic medical devices for therapeutic, diagnostic and monitoring technologies. We offer solutions for Cable and Interconnect solutions, Printed Circuit Board Assemblies (PCBA) and full device Box Build.

Medical Cable and Interconnect Assemblies

Qualtech is the industry expert in the design and manufacture of cable systems for medical devices. We focus on New Product Introduction (NPI) that incorporates the rigorous expectations of the medical device industry and global regulatory bodies.

We produce custom designed cable systems for medical applications from our FDA registered and ISO 13485 site. We have worked on a diverse range of medical applications ranging from minimally invasive, miniature/fine gauge cables up to larger, highly engineered harness systems.

Qualtech has ISO Class 7 and 8 cleanrooms available for specialized medical cable production and inspection.

Printed Circuit Board Assemblies (PCBA)

We have numerous high speed, fully traceable PCBA lines to produce rigid, semi-rigid and flexible PCBAs for medical technologies. We focus on the design demands of the medical application and work with you to identify the right components, lay out and substrate balancing regulatory, biocompatibility, mechanical and size constraints, to arrive at a design that is optimized for your device.

Box Build for Medical Electronics

Qualtech offers a full box build service where we provide a full electrical and mechanical assembly service. This can be part of a sub assembly or full system integration. This can include device specific configuration, software/firmware loading and custom testing. We Build to Order (BTO) and/or Configure to Order (CTO) as necessary.

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

Talk to Us Today

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