Optimize Combination Products:
Select a Platform Drug Delivery Device that Reflects Good Human Factors Engineering

By Erin Davis and Allison Strochlic, UL-Wiklund

A guide to the steps companies can take to evaluate their device developer’s HFE process.

Double Win:
Medtronic Receives FDA Approval and CE Mark for Aortic Valve

By MedTech Intelligence Staff

The Avalus pericardial surgical valve is intended for patients with aortic valve disease.

Devine Guidance

Is Dr. D Listed on Your Approved Supplier’s List?

By Christopher Devine, Ph.D.,
Devine Guidance International

Device establishments must maintain records of acceptable suppliers.

Featured Quote

Our device employs the latest photonics technology, allowing a user to make measurements of the vibration characteristics of the heart without even touching it.

— Mirko de Melis, CARDIS

Protecting Networks and Rapidly Treating Patients a Balance in Cybersecurity

By MedTech Intelligence Staff

The healthcare ecosystem needs to be more proactive in managing cybersecurity risks.

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IQ, OQ and PQ:
The Backbone of Your Quality System

By Edward Simpson, RS Calibration, Inc.

Know how IQ, OQ and PQ–the three essential elements of a Quality Assurance System–govern the medtech sector.

FDA’s Innovation Initiative Aims to Prevent Regulatory Barriers

By MedTech Intelligence Staff

The agency wants to modernize its regulatory processes and make them more efficient.