Emerging leader in medical imaging and diagnostics systems selects clinivation for a Leadership in Medical Device Safety initiative.
NATICK, MA – June 27, 2013 – Clinivation, Inc. is pleased to announce today that Samsung Electronics has selected clinivation to advance an important Leadership in Medical Device Safety initiative.
Among other elements, the engagement will consider:
Evidence-based approaches to medical device safety, comprising medical device defect taxonomy and classification, root cause analysis, and attribution to adverse event incidence and severity;
Process-based approaches to medical device safety, including structured assurance case methodologies, fully-integrated clinical experience and regulatory surveillance, extended-scope verification and design assurance, full policy enforcement of acceptance criteria for internal process deliverables, rigorous developer training and certification requirements, continuous internal audit functions, and maturity model development for measurement of organizational evolution; and
Product-specific approaches to medical device safety, including validation of broad and deep device interoperability, device performance and safety simulation, device software security, design for forensic and “flight data” analysis, extended verification of performance limits, and full validation of human factors engineering.
Quotes & Commentary:
“Medical device safety, quality, and zero defects are especially important for companies aspiring to global leadership in medical imaging and diagnostics systems,” said clinivation Founder and CEO Joseph Kozikowski, M.D. “I thank the Samsung Chief Technology Office for their leadership and support,” he continued.
For more information on the clinivation’s Technology-Enabled Professional Services, please visit the clinivation Professional Services homepage
About Samsung Electronics:
Samsung Electronics Co., Ltd. is a global leader in technology, opening new possibilities for people everywhere. Through relentless innovation and discovery, we are transforming the worlds of televisions, smartphones, personal computers, printers, cameras, home appliances, LTE systems, medical devices, semiconductors and LED solutions. We employ 236,000 people across 79 countries with annual sales of US$187.8 billion.