From its Stockholm headquarters, RaySearch Laboratories develops medical-device software for cancer treatment, including systems for treatment planning and oncology information management. Founded in 2000, the company works closely with cancer centers and supports thousands of clinics worldwide, with research and development concentrated in Sweden and subsidiaries across Europe, the Americas and Asia. Its quality system is certified to ISO 13485:2016, and its software is developed with patient safety and clinical integration in mind.
ISO 13485:2016
ISO 13485:2016 MDSAP
EC Certificate MDR
FDA Establishment Registration
Registration
21 CFR Part 820 US FDA Quality Systems Regulations
Compliance program
ISO 14971
Compliance program
IEC 61217
Compliance program
IEC 62083
Compliance program
IEC 62304
Compliance program
IEC 62366
Compliance program
IEC 62274
Compliance program
Sun NuclearFrom its Melbourne, Florida headquarters, Sun Nuclear develops quality-management solutions that help cancer centers check diagnostic imaging and radiation-therapy systems. Now part of Mirion Medical, the company combines software such as its SunCHECK connected workspace with measurement devices and phantoms, supporting independent QA at more than 6,000 cancer-treatment facilities in 130-plus countries. Its global support operation includes more than 20 medical physicists, backed by a 5,000-square-foot training center built to resemble a clinical setting.BALTIMORE, MD
Human Care GroupFounded in Sweden in 1993, Human Care Group develops medical devices that support mobility and safer patient handling, from rollators to lifting systems and ultralow healthcare beds. Headquartered in Stockholm, the group operates through companies and offices across Europe and North America, with products distributed worldwide. Its global quality management system is certified to ISO 13485:2016 and meets the requirements of 21 CFR Part 820.BELTSVILLE, MD
UE LifeSciences IncFounded in 2009, UE LifeSciences develops hand-held medical devices and digital tools that make early cancer detection more accessible, starting with its FDA-cleared iBreastExam for quick, painless, radiation-free breast-lump screening. Its Philadelphia-rooted, globally distributed team designs systems for community health workers and has supplied more than 2 million breast exams across 10 markets, with newer tools extending screening to cervical and oral cancer. The company also established an ISO 13485- and WHO-GMP-certified manufacturing facility in India as it expanded internationally.WEST CHESTER, PA
CQ MedicalCQ Medical develops patient-centric medical devices and positioning solutions for radiotherapy and related clinical care. Its work ranges from specialized supports such as Curvaform for kyphotic patients to systems used in veterinary oncology, where the company partners with more than 50 U.S. clinics. CQ Medical also maintains an external innovation process for ideas intended to improve clinical outcomes or reduce costs.AVONDALE, PA