MEDdesign

Using Agile Values for Medical Device Development

By Kenneth MacCallum, Starfish Medical

Although designed for software, Agile’s fundamental values are equally relevant to medical devices.

Medical Device Cybersecurity Conference to Address Vulnerabilities Facing Manufacturers and Hospitals with Legacy Devices

By MedTech Intelligence Staff

The vulnerability of legacy devices and systems can threaten patient safety and data privacy. Learn how to face these issues head on at this upcoming event.

Speaker Spotlight:
MedSec’s Stephanie Domas on
State of Cybersecurity

By Maria Fontanazza, Editor-in-Chief

Domas to share her insights at the MedTech Intelligence Cybersecurity conference in June 4–5 in Boston.

MEDdesign

510(k) Guidance Shifts Away Substantial Equivalence in Favor of Performance Testing and Criteria

By Jan Mansour,
EAS Consulting Group, LLC

This new pathway is a considerable change for the medical device industry.

Featured Quote

About half of all sterilized medical devices undergo sterilization using ethylene oxide. In view of the concerns about the environmental impact of this method, we recognize the importance of identifying new and improved ways of sterilizing medical devices.

— Scott Gottlieb, FDA

Soapbox

Keep Calm and Carry On...
And Other Outlooks We Can Apply to MDR Implementation

By Charlie Kim, Soom

With just over a year remaining before the EU MDR and IVDR regulations go into effect, many in the medical device industry are shifting their compliance efforts into high gear-a somewhat tedious task given the industry is still waiting on functional specifications for Eudamed.

• Medical Device Audits, Certification & Verification
• Quality & Regulatory Market Access Solutions
  sponsored by UL
• Medical Device Component
  sponsored by 3M
• Medical Recall

Obtaining an Accurate Proposal for Injection Molded Tooling and Parts

Anyone can use this list as the basis of an RFQ checklist for future injection molded projects. The more complete and accurate the information given to the injection molders is, the more accurate and reliable their proposals will be, and the more likely production of the part or parts will run on schedule, efficiently and cost-effective. This article discusses specific tips OEMs can put into practice to ensure all competing quotes they receive will be accurate and comparable.

Click to Download White Paper.

Science of Skin: Skin Through the Ages - White Paper

Skin is the boundary between who we are as we present ourselves to the world while acting as the barrier to the insults that we experience in our day-to-day existence. Skin is the largest organ in the body and as such it is critical to the maintenance of our bodies. If we suffer damage to our skin, we can suffer a loss of function.

Access White Paper here