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Section: Markets > Medical Device/Packaging
Providers Get The Message
Though its regulatory focus is usually on medical products and their makers and sellers, when the need arises, FDA writes letters to health care providers.
August 13, 2018
Focus on Data Quality to Prepare for Class III UDI Implementation
Medical device firms need to consider their data strategy and ensure the right structure is in place for establishing clean UDIs in order to contribute to patient safety.
November 3, 2017
Taking Wound Care Cues from Spiders
Is point-of-use nanofiber production the future of wound care? Harvard researchers inch closer to a system that could one day produce sterile bandages in the field.
April 21, 2017
Optimizing Production Tooling in Med Device Development
A new program from NyproMold helps medical device manufacturers bridge the gap from rapid-protyped parts to production-quality parts, accelerating new product introductions without sky-rocketing costs.
March 24, 2017
New Administration, New Regulatory Direction
Could radical changes be coming to the way drugs and devices are regulated, and what impact might that have on safety and effectiveness of products in commerce?
February 10, 2017
Medical Device Packaging Standards Expanding Globally
Standards aim to help manufacturers engineer devices to ensure safety and establish traceability ‘from womb to tomb.’ India and emerging markets may develop their own country-specific standards.
September 26, 2016
Packaging is Part of the Guidance Package
Medical device makers might need FDA guidance more than other manufacturers.
August 12, 2016
View From The Ground: UDI Implementation
A medical device consultant shares his perspective on the challenges to packagers of this new requirement.
June 24, 2016
Medical Devices and Packaging Demand Simultaneous Development
Sometimes the packaging of medical devices may be more challenging than the development of the device itself, reveals Dr. Jagdish Chaturvedi in this exclusive Q&A with Vimal Kumar, Healthcare Packaging’s Life Sciences from India Columnist.
June 14, 2016
Lives Over Landfills
Destined for the trash heap, unused, unopened and quality medical supplies could prevent millions of deaths.
March 28, 2016
FDA Commissioner Hold-Up
Proper qualifications are in the eye of the beholder—leading a complex agency is a complex job and it’s hard to find universal agreement on who’s best.
February 16, 2016
Rapid Growth Projected in India’s Healthcare Market
Foreign Direct Investment in the medical device sector, gains in medical equipment and diagnostics expected to drive 15% annual growth through 2015.
February 9, 2016
Medical Device Excise Tax Suspension to Rejuvenate U.S. Market
GlobalData analyst says two-year suspension will provide relief to small- and medium-sized device makers.
January 25, 2016
Regulated Environment: Process Validation in the Medical Device Industry
Packaging professionals in the medical device industry have different regulatory requirements than the packaging standards that apply to other products.
January 5, 2016
Have you come to grips with good design?
Good design takes into account real people in real-life situations.
November 12, 2015
Six Considerations for Providers to Maximize the FDA UDI Final Rule
Associating a unique identifier with a medical device is a crucial step toward increasing traceability, transparency, and accuracy across the healthcare supply chain.
November 9, 2015
What’s a regulatory crime?
Violations of the FDA’s requirements can put you in jail for a misdemeanor even if you didn’t intend to commit them.
September 21, 2015
FDA: Tougher or more lenient?
The figures on their enforcement are interesting, but it’s not always clear what message they send.
July 29, 2015
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