Medical & Life Science

Qualitel manufactures complex medical devices with the highest reliability and quality so you can focus on other important aspects of your business. We produce a variety of mission-critical electronic medical devices including ultrasound technology, surgical instruments and vital monitoring systems.

We have a successful track record of building CLASS II/III mission/life critical medical devices, from all aspects of assembly to CCA, functional test, final box-build, product labeling and packaging for distribution.

We understand that you simply cannot risk a defect which could mean product recalls, or lost lives. This is why Qualitel commits to manufacturing your mission-critical medical devices with a goal of 100% reliability, 100% on-time delivery, and extraordinary customer service 100% of the time. Our world-class facility, state-of-the-art equipment, and industry knowledge and expertise help us as we strive to achieve these goals.

Qualitel’s testing services give you peace of mind that we’ve manufactured your medical device right the first time. We offer more comprehensive testing services than most electronics manufacturing services providers. Unlike some competitors, we can develop and do all testing in-house to maintain the control necessary to deliver high quality medical electronics that work for the life of your product, saving you money over its lifetime.

Since 2005, Qualitel has complied with the requirements of ISO 13485:2016 to provide a full range of electronics manufacturing services for the medical device industry. Services include turnkey prototyping, circuit card assembly, testing, repair and box-build. Manufacturing services covered by the certificate of registration include BGA (Ball Grid Array), SMT (Surface Mount Technology), wave, selective and hand soldering, in-circuit/flying probe and functional test, conformal coating, potting and encapsulation and X-ray.

In addition to being ISO13485:2016 compliant, Qualitel is ISO 13485:2016 Registered and has a stellar record with other regulatory agencies. Since 2001, Qualitel has been a FDA registered facility with 100% compliance to FDA audits every two years. Our manufacturing employees are IPC-A-610 and J-STD-001 certified, with on-site training for new employees and re-certification.

Here’s why medical device customers have selected Qualitel to provide electronics manufacturing services:

  1. State-of-the-art equipment we have to build and test their products
  2. A stellar record of compliance to medical industry required registrations and certifications (FDA, ISO13485 Medical).
  3. We continue to successfully manufacture products for Top Tier medical device customers.

Contact us today to learn more about how you can achieve peace of mind by partnering with Qualitel! Let us do what we do best so you can concentrate on other important aspects of your business.

Registrations & Certifications