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Quality/Regulatory

Featured Articles

February 26, 2021
FDA

FDA Authorizes New Device that Protects the Brain From Head Hits

By MedTech Intelligence Staff

The Q-Collar uses jugular compression to help protect an athlete’s brain from the effects of repetitive head impacts.

February 24, 2021
Coronavirus

Rice University Gets Up to $1 Million to Develop Sensor that Detects Airborne COVID-19

By MedTech Intelligence Staff

The real-time bioaerosol sampling system can detect a very low concentration of SARS-CoV-2 in the air.

February 23, 2021
Whitehouse 2021

President Biden Nominates Chiquita Brooks-LaSure to CMS Administrator

By MedTech Intelligence Staff

Brooks-LaSure has more than two decades of experience in health policy and played a crucial part in the passage of the Affordable Care Act.

February 17, 2021
FDA

In 2020, FDA Authorized 132 Novel Medical Devices

By MedTech Intelligence Staff

The record-high number of authorizations last year was a significant jump over 2019.

February 10, 2021
Cybersecurity, healthcare

More Cyberattacks in Healthcare, Yet Most MedTech Leaders Unprepared, Says Survey

By MedTech Intelligence Staff

A mere 13% of IoMT leaders believe their organization is in a good place to mitigate future risks related to cybersecurity.

February 4, 2021
Kevin Fu, University of Michigan

FDA Names Acting Director of Medical Device Cybersecurity

By MedTech Intelligence Staff

The agency created the new post within CDRH, effective January 1.

January 29, 2021
Alert

COVID-19 Introduces New Risks, Hazards in Health Tech

By MedTech Intelligence Staff

With the accelerated adoption of many new technologies, ECRI’s annual health technology hazards list has been transformed by the COVID-19 pandemic.

January 20, 2021
Janet Woodcock, M.D., FDA

CDER Director Janet Woodcock to Serve as Interim FDA Commissioner

By MedTech Intelligence Staff

Woodcock was selected by outgoing Commissioner Stephen Hahn, M.D.

View More Quality/Regulatory Articles »

Columns

February 10, 2021
Soapbox

Five Best Practices to Grow MedTech Leadership Talent in Turbulent Times

By Beth Doladee, Neelima Paranjpey, Ph.D.
The Vaya Group

In an industry fraught with constant challenges, medtech leaders need to close the growing skills gap of their employee base and develop leadership from within. The pandemic’s impact on an increasingly remote workforce has caused companies to adopt a new approach to cultivating emerging leaders.

February 9, 2021
MEDdesign

Strategic National Stockpile Ventilators Can Support ‘Most’ Patients, but That Is Not Enough

By Sam Alnajjar, M.D.
Sam Alnajjar, M.D.

Critical care hasn’t had many breakthroughs in recent years and in order to change that, I believe we need to put more of an emphasis on integrating technology—specifically artificial intelligence (AI) —into the field.

January 27, 2021
Soapbox

Regulatory Information Management Streamlines Processes and Supports Data Quality

By Romuald Braun
Romuald Braun, Amplexor

Data integration is doing much to enhance regulatory information management. Life sciences companies are increasingly discovering useful interdependencies between data, documents and RIM processes. The next step is to put this data to work to improve efficiency.

January 21, 2021
MEDdesign

Avoiding FDA Enforcement Actions: Understanding Quality Systems

By Amy Scanlin

The greatest challenge faced is an understanding of the intent of the written regulations and applying them correctly.

January 4, 2021
MEDdesign

Compliance Is Compulsory, and Product Labeling Is No Exception

By Beth Peckover
Beth Peckover, Kallik

For pharmaceutical and medical device manufacturers, computerized systems validation is vital. The following are three areas businesses must fine tune to ensure computerized labeling systems meet the stipulations of the new GxP regulations.

Upcoming Events & Webinars

March 12, 2021 – 1:00 pm – 2:00 pm
Medical Device Regulation – MDR Transition Update
March 30, 2021 – 12:00 pm – 2:30 pm
EU IVDR Introduction (EU IVDR Innovation in Practice Virtual Event Series)
April 6, 2021 – 12:00 pm – 2:30 pm
Quality Processes and Documentation (EU IVDR Innovation in Practice Virtual Event Series)
April 13, 2021 – 12:00 pm – 2:30 pm
Clinical Evidence & Surveillance (EU IVDR Innovation in Practice Virtual Event Series)


On Demand Events & Webinars

March 12, 2021 – 1:00 pm – 2:00 pm
Medical Device Regulation – MDR Transition Update
February 10, 2021 – 1:00 pm – 2:00 pm
Bringing Digital Transformation to Your Supply Chain: Connecting OEMs & Contract Manufacturers for Improved Performance
February 9, 2021 – 1:00 pm – 2:00 pm
ISO 14971:2019 Risk Management for Medical Devices
January 28, 2021 – January 28, 2021
Computer Modeling & Simulation in MedTech Product Development & Submissions (Day Two)
January 27, 2021 – January 27, 2021
Computer Modeling & Simulation in MedTech Product Development & Submissions (Day One)
December 16, 2020 – 1:00 pm – 2:30 pm
Connected Medical Devices & the Cloud
August 20, 2020 – 1:00 pm – 2:00 pm
2021 – Preparing for Changes in the EU MDR Complaint Management and Vigilance Regulations
July 28, 2020
Defend Against MedTech Cyber Breach: A Fireside Chat with Critical Healthcare Stakeholders
May 21, 2020 – 1:00 pm – 2:00 pm
Emergency Use Authorization (EUA)
May 20, 2020 – 1:00 pm – 2:00 pm
Improving the safety, visibility & transparency of your supply chain during a crisis to sustain customer confidence

Quality/Regulatory Archive





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