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(ISO: Geneva) -- While some countries have made great progress toward universal health coverage, half the world’s population are still unable to obtain the health services they need. The International Organization for Standardization (ISO) and the World Health Organization (WHO) are working…
(FDA: Silver Spring, MD) -- The U.S. Food and Drug Administration has published an Electronic User Guide for its Accredited Third-Party Certification Program Portal.
In this voluntary program, established by the FDA Food Safety Modernization Act, the agency recognizes “accreditation bodies” that…
(Greenlight Guru: Indianapolis) -- Greenlight Guru, the only quality management software platform designed specifically for medical device companies, announces a new integration with Jira, creating an adaptive system for managing product development and post-market quality for devices with software…
(CRC Press: Boca Raton, FL) -- In the book, Health Care in the Next Curve (CRC Press, 2018), author John Abendshien takes an objective and sometimes scathing look at the current industry structure: a silo-driven culture and entrenchment that is driven by self-interest, as well as the complicity of…
(CBI UBM: Burlington, MA) -- IVT Network, the trusted source for life sciences validation and compliance knowledge, is featuring its flagship event, the 24th Annual Validation Week Oct. 22–24, 2018, in San Diego. Melanie Demakis, IVT’s senior conference producer, recently worked with Connie Hetzler…
(ISO: Geneva) -- The Food and Drug Administration (FDA), an agency within the U.S. Department of Health and Human Services, announced its intention to use ISO 13485 as the basis for its quality system legislation.
The International Organization for Standardization’s (ISO) international standard, …
(MIT News: Cambridge, MA) -- Using a machine-learning system known as a deep neural network, MIT researchers have created the first model that can replicate human performance on auditory tasks such as identifying a musical genre.
This model, which consists of many layers of information-processing…
(Sparta Systems: Hamilton, NJ) -- A recent survey sponsored by Sparta Systems and conducted by Pharmaceutical Technology, found that while compliance remains the top objective in 2018 among 73 percent of pharmaceutical executives, performance-oriented objectives were nearly as critical for the…
(marcus evans: London) --The Information Management and Data Quality for Pharma Sector Conference, organized by the marcus evans Group, will focus on gathering corporate professionals from regulatory operations, regulatory affairs, master data management, regulatory information systems, and other…
(FDA: Silver Spring, MD) -- The field of regenerative medicine encompasses a wide scope of innovative products including cell therapies, therapeutic tissue engineering products, human cell and tissue products, and certain combination products using such therapies. Examples include genetically-…
(BioCision: San Rafael, CA) -- BioCision LLC, a life science research and development company that standardizes basic laboratory processes, has announced the formation of MedCision Inc., an independent company focused on automation of pre-clinical and clinical processes.
“The formation of…
(Control Micro Systems: Orlando, FL) -– Control Micro Systems (CMS) has developed turnkey laser marking and cutting systems for industry-leading clients in the medical sectors.
Manufacturers of endoscopic guidewire devices frequently are required to mark brand and model information as well as…
A new imaging technique developed by scientists at MIT, Harvard University, and Massachusetts General Hospital (MGH) aims to illuminate cellular structures in deep tissue and other dense and opaque materials. Their method uses tiny particles embedded in the material, that give off laser light.…
(FDA: Washington, D.C.) -- The U.S. Food and Drug Administration (FDA) has awarded a total of $21.8 million to support 42 states to help implement the FDA Food Safety Modernization Act (FSMA) produce-safety rule. The rule, which the FDA finalized in November 2015, establishes science-based minimum…
(Productivity Press: Boca Raton, FL)) -- Shingo award winner and bestselling author Tom Zidel’s newest book, Rethinking Lean in Healthcare (Productivity Press, 2016) deals with hospitals’ struggle to secure and maintain financial stability. In story form, Zidel tells how the leadership team of a…
(marcus evans: London) -- Pharmaceutical quality systems have shifted in recent years from a traditional model to a more global, dynamic, and risk-based approach, enhanced especially by regulatory authorities and economic environment. marcus evans is organizing the conference, “Quality Risk…
(Productivity Press: New York) -- You likely don’t need any more tools, programs, or workshops to improve your hospital. What you need is a simple and consistent approach to manage problem-solving. Filling this need, Lean Daily Management for Healthcare: A Strategic Guide to Implementing Lean for…
(FDA: Washington, DC) -- During the last few months, we’ve shared what the FDA is doing to improve the review of combination products, including establishing the Combination Product Council and identifying necessary process improvements through lean mapping of the combination product review…
(CRC Press: Boca Raton, FL) -- In a cool and readable style, Andy & Me and the Hospital: Further Adventures on the Lean Journey follows Tom Pappas’s relationship with Andy Saito, a reclusive retired Toyota guru. Tom and Andy are pulled into a major New York City hospital in crisis. Can they…
(ISO: Geneva) -- Exposure to ionizing radiation is a potential risk in many situations, and the International Organization for Standardization (ISO) has a score of standards that help ensure exposure levels are kept within safe limits. Now, two new standards have been published that focus on the…
(NIST: Gaitherburg, MD) -- Medical devices such as the infusion pumps that deliver medication intravenously were once standalone instruments that interacted only with the patient. Today, they have operating systems and communications hardware that allow them to connect to other devices and…
(MOCON: Minneapolis) -- Cleanroom operators will now be able to detect the presence of extremely low levels of microbial cells on surfaces much faster than with traditional solutions. This cleanroom testing capability is a result of a global marketing agreement between MOCON Inc. and Particle…
Taking a cue from Toyota, the newly published book Lean Culture Change Using a Daily Management System (Align Kaizen, 2015) by lean transformation coach and author Steven Leuschel applies decades of organizational transformation knowledge deeply rooted in the Toyota Production System and in Toyota…
(ANSI) -- The Food and Drug Administration (FDA) is requesting feedback on the use of the term “natural” in food labeling. The action is a response to consumers who have requested that the administration explore the use of this term on food labels, considering the changing landscape of food…
(Gartner: Stamford, CT) -- Gartner Inc. has released its seventh annual Healthcare Supply Chain Top 25 ranking. The 2015 ranking recognizes companies across the healthcare value chain that demonstrate leadership in improving patient care and lowering costs.
"Alignment to patient outcomes, company…
