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 manufacturing 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?
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
“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.”
“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”