White Papers

Are You Ready for UDI?

Dassault Systemes

In an effort to improve the quality of information in medical device adverse event reporting, reduce recalls and improve patient safety, in 2007 the United States Congress passed legislation directing the FDA to develop regulations establishing the u...

Are You Ready for UDI?

Beyond the ID: the Value of UDI Championing the Patient

Dassault Systemes

The implementation of unique device identification (UDI) will have a profound effect on med-tech manufacturers, healthcare providers, regulators and ultimately the patient.

Beyond the ID: the Value of UDI Championing the Patient

Force Sensors For Design

Tekscan

In recent years, factors such as consumer demand and a tough economy have pushed OEMs to produce sleeker, smaller, and less costly products than in the past.

Force Sensors For Design

Beyond Trade-offs: How Medical Device Manufacturers can Balance Innovation, Quality and Compliance While Improving Profit

Dassault Systemes

The medical device industry has always been dependent upon product innovation to drive growth. With today's aging global population and expectations for living to an older age, the medical device industry is poised for a sustained period of extreme g...

Beyond Trade-offs: How Medical Device Manufacturers can Balance Innovation, Quality and Compliance While Improving Profit

Improving Medical Devices With Force Sensing Technology

Tekscan

Design engineers integrate force sensors into medical devices to create smart tools that produce quantifiable data.

Improving Medical Devices With Force Sensing Technology

Connecting the Dots Between Quality, Engineering, and Regulation to Increase Innovation and Improve Operational Efficiency

Dassault Systemes

Medical device companies often face responsibilities associated with developing, producing, and distributing products that improve quality of life.

Connecting the Dots Between Quality, Engineering, and Regulation to Increase Innovation and Improve Operational Efficiency

Biopsy Devices: Emerging Markets to Drive Growth

GlobalData

The biopsy devices market has benefitted from being suitable for the diagnosis of a variety of cancer indications, and is set to reach $602.4m by 2019, at a global compound annual growth rate (CAGR) of 2.93%.

Biopsy Devices: Emerging Markets to Drive Growth

Medical Devices: Supporting a Patient-Driven Market

Dassault Systemes

Medical device companies are under a lot of pressure from all of their stakeholders, including patients, health care providers, shareholders and regulatory agencies around the world.

Medical Devices: Supporting a Patient-Driven Market

Safety in Medical Electrical Equipment Starts with the Power Input

SCHURTER Electronic Components

Electrical equipment used in medical technology must not place patients or medical staff in danger. This, in turn, requires that designing safe equipment starts at the point where the power is supplied.

Safety in Medical Electrical Equipment Starts with the Power Input

Strategies to Prevent Infections Caused by Medical Devices

BSL BIOSERVICE

The infection rate in hospitals after a surgery is an increasingly severe issue in many countries of Europe and in the US. About 1.5% of implants induce complications due to infections. One strategy to prevent these infections is to coat the surface ...

Strategies to Prevent Infections Caused by Medical Devices

Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse

medicaldevice-network.com

The US Food and Drug Administration (FDA) has issued a Public Health Notification (PHN) to inform clinicians and patients of adverse events related to urogynecologic use of surgical mesh, as well as to provide recommendations on how to mitigate risks...

Urogynecologic Surgical Mesh: Update on the Safety and Effectiveness of Transvaginal Placement for Pelvic Organ Prolapse

Integrating Quality by Design (QbD) in Medical Device Manufacturing - Concept, Benefits and Challenges

medicaldevice-network.com

This white paper discusses the Quality by Design (QbD) concept and its integration into the medical devices industry, along with its uses and challenges expressed by manufacturers.

Integrating Quality by Design (QbD) in Medical Device Manufacturing - Concept, Benefits and Challenges

Medical Device Home Use Initiative

medicaldevice-network.com

Medical Device Home Use Initiative

Medical Device Home Use Initiative

Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses

medicaldevice-network.com

Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses

Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses

CDRH Innovation Initiative

medicaldevice-network.com

CDRH Innovation Initiative

CDRH Innovation Initiative

Maximising Profit Capture for Medical Device Manufacturers

medicaldevice-network.com

Maximising Profit Capture for Medical Device Manufacturers

Maximising Profit Capture for Medical Device Manufacturers

Five Steps to Validating the Cleaning Process of Medical Devices

medicaldevice-network.com

Five Steps to Validating the Cleaning Process of Medical Devices

Five Steps to Validating the Cleaning Process of Medical Devices

The Risks to Medicare Beneficiaries of DMEPOS Competitive Bidding: Considerations for the Round One Rebid and Beyond

medicaldevice-network.com

The Risks to Medicare Beneficiaries of DMEPOS Competitive Bidding: Considerations for the Round One Rebid and Beyond

The Risks to Medicare Beneficiaries of DMEPOS Competitive Bidding: Considerations for the Round One Rebid and Beyond

Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011

medicaldevice-network.com

Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011

Guidelines for the Prevention of Intravascular Catheter-Related Infections, 2011

Intelligent Medical Devices in Hospitals: An Overview

medicaldevice-network.com

Intelligent Medical Devices in Hospitals: An Overview

Intelligent Medical Devices in Hospitals: An Overview

External Defibrillator Improvement Initiative

medicaldevice-network.com

External Defibrillator Improvement Initiative

External Defibrillator Improvement Initiative