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India’s New Medical Devices Rules
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Supply Chain
Device Sectors
3D/Additive Manufacturing
Mike on Medtech: 3D Printing Healthcare at the Point of Care
Sean Fenske and Mike Drues discuss the regulatory implications with 3D printing devices at a healthcare facility.
Sean Fenske, Editor
03.23.18
Mike on Medtech: Quality vs. Regulatory
Mike Drues and Sean Fenske discuss these interrelated terms and their relevance to the industry, while offering examples.
Sean Fenske, Editor-in-Chief
03.02.18
Mike on Medtech: The 'New' Alternative 510k
Mike Drues and Sean Fenske discuss a recently announced 510(k) pathway that actually resembles an already existing option.
Sean Fenske, Editor
01.29.18
Materials
Mike on Medtech: Regulatory Approval Pathway for Biomaterials
Mike Drues and Sean Fenske discuss the potential advantages of implementing an approval pathway for biomaterials.
Sean Fenske, Editor
01.02.18
R&D & Design
|
Testing
Mike on Medtech: Pre-Sub with the FDA
Mike Drues and Sean Fenske discuss the benefits of the FDA's pre-submission review process for medical device manufacturers.
Sean Fenske, Editor
11.06.17
R&D & Design
|
Testing
Mike on Medtech: Human Factors
Mike Drues and Sean Fenske discuss the importance and benefits of human factors design in medical device development.
Sean Fenske, Editor
10.09.17
Cardiovascular
|
Diagnostics
|
Digital Health
|
Neurological
|
Patient Monitoring
|
Surgical
Mike on Medtech: MDUFA IV and Its Impact on Medtech Innovation
Mike Drues and Sean Fenske discuss the harmful effect the latest version of MDUFA could have on medtech development.
Sean Fenske, Editor
09.07.17
Cardiovascular
|
Diagnostics
|
Digital Health
|
Neurological
|
Patient Monitoring
|
Surgical
Mike on Medtech: Off-Label Use
Mike Drues and Sean Fenske discuss the off-label use of medical devices and the promotion of such use.
Sean Fenske, Editor
08.25.17
Materials
Mike on Medtech: Biomaterials, Biocompatibility, and Bioabsorbable
Mike Drues speaks with Sean Fenske to discuss biomaterials, biofriendly, biocompatible, bioabsorbable, and more.
Sean Fenske, Editor
07.24.17
3D/Additive Manufacturing
Mike on Medtech: 3D Printing in Healthcare
Mike Drues joins Sean Fenske to chat about the role of 3D printing in medtech and healthcare today and challenges that exist.
Sean Fenske, Editor
06.05.17
R&D & Design
Mike on Medtech: Reimbursement for Engineers
A look at the relationship between medical device reimbursement and medtech product design and development.
Sean Fenske, Editor
05.05.17
Cardiovascular
|
Diagnostics
|
Digital Health
|
Neurological
|
Patient Monitoring
|
Surgical
Mike on Medtech: Device Incident Reporting
Sean and Mike discuss the topic of hospitals reporting medical device incidents and what needs to change with the process.
Sean Fenske, Editor
03.30.17
Mike on Medtech: Real World Evidence
Mike Drues of Vascular Sciences offers insights into the use of real world evidence in medtech regulatory approval processes.
Sean Fenske, Editor
02.24.17
Breaking News
Remote Control Fires Laser at Nano-Gold to Activate Cancer-Killing Immune Cells
FDA Clears Varian's Calypso Anchored Beacon Transponder for Lung
Clinical Trial Tests 'Tattoo Sensor' as Needleless Glucose Monitor
Chip-Based Multiple Myeloma Blood Test Could Eliminate Need for Bone Biopsies
Pear Therapeutics and Novartis Ink Deal to Commercialize Prescription Digital Therapeutics
View Breaking News >
CURRENT ISSUE
April 2018
India’s New Medical Devices Rules
Discovering Packaging’s Hidden Value
Deliberate Disposal: Single-Use & Disposables Technologies
Illuminating Tubing’s Future
View More >