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Dr. Christopher Joseph Devine, President, Devine Guidance International
November 4, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

I Am Not Aware of a Quality System: Seriously?

You need a management representative with oversight over medical device quality.

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UL LLC
October 24, 2015
UL LLC

China Stiffens Software Requirements for Medical Devices

How do the latest requirements affect your business?

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October 13, 2015

CDRH’s Shuren: Future is Bright, We Need to Take Risks

By Maria Fontanazza

As the agency continues to try to do more with fewer resources, taking additional risks is imperative to move forward.

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Human factors, use error
October 5, 2015
Human factors, use error

Medical Device Use Error: Stop Blaming Users

By Maria Fontanazza

When assessing the root cause of a use error, look at the user interface before pointing fingers.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
September 23, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

One, Two, Three Strikes You’re Out…Or, Receive a Warning Letter

By Dr. Christopher Joseph Devine

It is in the best interest of an offending establishment to be timely and complete in responding to Form 483 observations.

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Roberta Goode and Julie Cabezas, Goode Compliance International
September 8, 2015
Roberta Goode and Julie Cabezas, Goode Compliance International

Considerations When Using Postmarket Data in Risk Management

By Roberta Goode, Julie Cabezas

A review of how to incorporate complaint handling and risk management into the postmarket surveillance process.

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The intersection of complaint handling, risk management and postmarket surveillance in the medical device industry
September 1, 2015
The intersection of complaint handling, risk management and postmarket surveillance in the medical device industry

The Integration of Complaint Handling and Risk Management

By Roberta Goode, Julie Cabezas

A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.

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UL LLC
August 21, 2015
UL LLC

Ask the Expert: EU Regulations and Clarification for Products Used in Day Spas

Get the latest advice on existing and future requirements.

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Dr. Christopher Joseph Devine, President, Devine Guidance International
August 18, 2015
Dr. Christopher Joseph Devine, President, Devine Guidance International
Devine Guidance

Only Two Form 483 Observations Can Equate to a Warning Letter

By Dr. Christopher Joseph Devine

You must have established procedures for complaint management and MDRs.

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August 3, 2015
Ameing for Asia

Finding Reliable Key Opinion Leaders in Asia Is Trickier Than You Think

By Ames Gross

Do your due diligence and make sure you have experienced, native boots on the ground.

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Columns

May 14, 2024

FDA Issues Final Guidance on Remanufacturing of Medical Devices

By MedTech Intelligence Staff
FDA Logo

The guidance defines remanufacturing, includes relevant considerations to determine if activities are remanufacturing, and provides recommended labeling information to ensure serviced devices are returned to their established performance and safety specification.

May 1, 2024

FDA Releases Laboratory Developed Tests Final Rule

By MedTech Intelligence Staff
FDA Logo

“The final rule announced today aims to provide crucial oversight of these tests to help ensure that important healthcare decisions are made based on test results that patients and health care providers can trust.”

April 10, 2024

Federal Court Enters Consent Decree Against Philips Respironics Following Recall of CPAP Machines

By MedTech Intelligence Staff
Gavel

The consent decree restricts the production and sale of new continuous positive airway pressure (CPAP) machines, bi-level positive airway pressure (BiPAP) machines and other devices at several Philips Respironics facilities in the U.S. until certain requirements are met.

April 3, 2024

FDA to Host Virtual Workshop on ASCA Program Expansion

By MedTech Intelligence Staff
FDA Logo

On April 17, the FDA is hosting a Virtual Public Workshop on approaches to Accreditation Scheme for Conformity Assessment Expansion.

March 25, 2024

FDA Proposes Ban on Electrical Stimulation Devices

By MedTech Intelligence Staff
FDA Logo

“These devices present a number of psychological risks including depression, anxiety, worsening of underlying symptoms, development of post-traumatic stress disorder, and physical risks such as pain, burns, and tissue damage.”

March 17, 2024

FDA Outlines its Approach to Artificial Intelligence Regulation

By MedTech Intelligence Staff

“Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” outlines how FDA’s medical product centers plan to address regulation of AI used in medical products and their development.

February 20, 2024

FDA Urges Medical Device Manufacturers to Scrutinize Third Party-Generated Data

By MedTech Intelligence Staff
FDA Logo

Following a “alarming” increase in medical device submissions containing unreliable data, the FDA is reminding manufacturers and study sponsors that they are responsible for qualifying third-party test labs and closely scrutinizing all testing data.

January 31, 2024

FDA Elevates Office of Strategic Partnerships and Technology Innovation to CDRH Super Office

By MedTech Intelligence Staff
FDA Logo

As part of its reorganization of the CDRH, the FDA has elevated the Office of Strategic Partnerships and Technology Innovation (OST) to a Super Office that will include the Office of Supply Chain Resilience (OSCR), Digital Health Center of Excellence (DHCoE), Office of Technology and Data Services (OTDS), Office of Readiness and Response (ORR) and Office of Equity and Innovative Development (OEID).

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  • MedTech Economics
  • Manufacturing Execution
  • Product Design & Development
  • Quality/Regulatory

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