White Papers

Unique Device Identification of Medical Devices

FOBA / ALLTEC GmbH

UDI is a unique device identification system created and regulated by the US Food and Drug Administration (FDA).

Unique Device Identification of Medical Devices

How to Create a Reliable Laser Marking on Medical Stainless Steel Devices

FOBA / ALLTEC GmbH

In view of its optimum compatibility with the identification requirements in medical technology, laser technology represents the solution for marking medical devices made of virtually any material.

How to Create a Reliable Laser Marking on Medical Stainless Steel Devices

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

Review of Process Standards Risk Management Usability PEMS and Software

Intertek

Regardless of what product development stage you are in, Intertek can help you speed-up your time to market. As medical device manufacturing companies work to embrace the sometimes complex factory production control and extended documentation require...

Review of Process Standards Risk Management Usability PEMS and Software

Electromagnetic Compatibility (EMC) for Active Implantable Medical Devices

Intertek

The role of electromagnetic compatibility in implantable medical device design and testing has become increasingly important as we rely more and more on electronics in our lives.

Electromagnetic Compatibility (EMC) for Active Implantable Medical Devices

IEC 60601-1: The New Philosophy of the 3rd Edition

Intertek

The 3rd Edition of IEC 60601-1 represents a shift in philosophy from the 2nd Edition, including a greater emphasis on risk management and essential performance. As with any other standard change, a failure to implement these new requirements in a tim...

IEC 60601-1: The New Philosophy of the 3rd Edition

Fluidic Systems for Critical Applications

Gems Sensors & Controls

Experience. It's more than "years in business". It's about what you've done and how you do it. It's about your capacity to deliver the right solutions.

Fluidic Systems for Critical Applications

Fluid Handling in Medical Device Design: Issues and Challenges

Gems Sensors & Controls

This white paper will review key challenges and emerging trends in fluidics design, and will explore considerations for achieving the best results when working with contract design and manufacturing firms.

Fluid Handling in Medical Device Design: Issues and Challenges

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

Welding and Engraving Services for the Medical Industries

CS Industries

Welding and Engraving Services for the Medical Industries

Welding and Engraving Services for the Medical Industries

External Defibrillator Improvement Initiative

medicaldevice-network.com

External Defibrillator Improvement Initiative

External Defibrillator Improvement Initiative

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

medicaldevice-network.com

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging