How The VA Is Improving Cybersecurity
It’s no surprise that organizations across industries are taking measures to ensure top medical device cybersecurity for their clients, customers and products. Government entities are certainly no strangers to this process. The Department of Veterans Affairs recently...
read moreImpact of EU MDR on Notified Bodies
As medical device companies are beginning to transition towards the EU Medical Device Regulation standards, there is no denying that Notified Bodies are also making strides to meet the May 2020 deadline. According to a recent article, the new regulations include...
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Understanding the FDA Cybersecurity Go-Team
The U.S. Food and Drug Administration (FDA) recently unveiled the Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, a comprehensive plan with the goal of assessing processes and procedures in order to enhance medical device security in an ever-evolving technological landscape.
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From On-Screen To Real Life
The US Food and Drug Administration (FDA) recently released a new medical device safety action plan that contains five focus areas that aim to improve the quality of real-world evidence, improve post-market surveillance, spur innovation around safer devices, advance cybersecurity initiatives and reorganize the Center for Devices and Radiological Health (CDRH).
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Being Local Isn’t Enough
The problem consumers experience when buying local, she explains, is the lack of already cooked and prepared foods. In today’s fast-paced world, not everybody has time to cook a full meal every day.
read moreLooking To New Opportunities Within Medical Device Reimbursement: Interview with John Joseph, Electromed
John Joseph is the Director of Managed Care Payer Contracts at Electromed. He will be on a panel at the upcoming 14th Annual Medical Device Coverage & Reimbursement Conference on July 11-12 in Chicago, IL. Mr. Joseph is presenting in the panel discussion:...
read moreExploring Data Privacy & Cybersecurity: An Interview with Dr. Mansur Hasib, CISSP, PMP, CPHIMS
Dr. Mansur Hasib CISSP, PMP, CPHIMS is the Program Chair, Cybersecurity Technology at The Graduate School, University of Maryland University College. He will be presenting at the upcoming Life Science Data Privacy Governance & GDPR Alignment on July 26-27...
read morePreparing for IVDR: Interview with Dr. Andreas F. Stange
Dr. Andreas F. Stange is the Vice President MHS global IVD with TÜV SÜD. He will be presenting at the upcoming EU IVDR Transition & Implementation Workshop Intensive on July 13 in Alexandria, VA. Looking to better understand how to navigate the IVDR...
read moreThe Importance of Strong Supplier Quality Relationships
The Importance of Strong Supplier Quality Relationships Interview with Paul Hakamaki, 3M Paul Hakamaki is the Global Supplier Quality Process Leader within 3M’s Health Care Business Group. He will be presenting at the upcoming 8th Semi-Annual Risk Based Medical...
read moreStéphane Dattenny – BIOGEN
Pharmaceutical Manufacturing Execution Systems Conference: Speaker Interview May 23-24th | Chicago, IL
read moreBrian DiVasta – Genzyme
3rd Annual Pharmaceutical Manufacturing Execution Systems Conference speaker interview
read moreKathleen Crossman – FONA International Inc.
Conversation with Kathleen Crossman, Vice President of Regulatory at FONA International. She will be speaking at the Food Labeling Workshop on April 17th.
read moreChristina DeLuca – Merck & Co., Inc.
Pharmaceutical Clinical Quality Compliance & Risk Management Conference
read moreBill Hagestad – Smiths Medical
2nd Annual Medical Device Cybersecurity Risk Mitigation Conference: Speaker Interview
read moreDavid Festa – CooperSurgical
Semi-Annual Medical Device Supplier Quality Conference: Speaker Interview
read moreApple is launching medical clinics to deliver the ‘world’s best health care experience’ to its employees
On the tails of Amazon, Berkshire Hathaway and J.P. Morgan announcing their joint effort to improve health care for their employees, Apple announces that they are launching a group of health clinics called AC Wellness this spring. Read the full store here.
Concussions Can Be Detected With New Blood Test Approved by F.D.A.
The Food and Drug Administration on Wednesday approved a long-awaited blood test to detect concussions in people and more quickly identify those with possible brain injuries.
The test, called the Banyan Brain Trauma Indicator, is also expected to reduce the number of people exposed to radiation through CT scans, or computed tomography scans, that detect brain tissue damage or intracranial lesions. If the blood test is adopted widely, it could eliminate the need for CT scans in at least a third of those with suspected brain injuries, the agency predicted. Read the full story here.
Amazon, Berkshire Hathaway and JP Morgan Chase join forces to tackle employees’ health-care costs
Three major employers, Amazon, Berkshire Hathaway and JP Morgan Chase, announced Tuesday they were partnering to create an independent company aimed at reining in health-care costs for their employees. What could this mean for the future of health care? Click here to find out.
FDA releases top 3 medical device regulation goals
Setting goals helps everyone do better. The FDA is no different. They have released the top 3 device regulation goals for the next three years. These include improving employee engagement, increasing simplicity and building collaborative communities. To read more about the strategies being put in place, click here.
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