FDA Squashes Five
Cybersecurity Myths

By Maria Fontanazza, Editor-in-Chief

The agency clarifies some misconceptions about requirements.

Barcoding in the NHS
and the run-up to UDI

By Peter Rose, Maetrics

UK and European manufacturers should put a UDI implementation plan in place ASAP.

Featured Quote

Can (or do) your distributor candidates make a business plan for your planned product launch, and if so, how important is it in your decision of whether or not to entrust them with your business?

— Rafael Mazuz, Diligence Wound Care Global, LLC

Test your ISO 13485 IQ

Part II

By MedTech Intelligence Staff

Part II of the ISO 13485 IQ test digs a little bit deeper into the standard.

Cardinal Health Picks Up Medtronic’s Patient Monitoring and Recovery
Division for $6.1 Billion

By MedTech Intelligence staff

Medtronic will keep its respiratory and monitoring solutions business, while Cardinal will buy the patient care, DVT, and nutritional insufficiency businesses.

Devine Guidance

Inform FDA of Design Changes!

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

If device modifications could affect safety and effectiveness, a premarket notification submission is required.

Incorporating Human Factors Engineering into Product Development

By Jon Tilliss and Allison Strochlic,
UL-Wiklund

Companies should not underestimate the importance of investing in user experience design.