|
|
|
By Gopiganesh Chandra Sekaran, Baxter International Inc. | The recent update to ISO 15223-1, formalized through Amendment 1:2025, ushers in a critical shift for medical device labeling from the legacy “EC REP” symbol to a more flexible, jurisdiction-specific format: “XX-REP.” | |
|
|
|
By Marcelo Trevino, independent expert | This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China, Brazil, Australia, and South Korea are approaching AI in medical devices. | |
|
|
|
By Jesper Madsen Wagner and Thomas Bo Sølver, NIRAS | In the life sciences, audits have long been bogged down by repetitive tasks. AI is changing the way auditors operate, making compliance more seamless than ever. | |
|
|
|
|
| FAQs On The Revised EU GMP Annex 1: Volume 2 | Article | West Pharmaceutical Services, Inc. | Review the implementation of a holistic Contamination Control Strategy (CCS). Discover four key considerations for assessing component readiness: product, process, protection, and proof. |
|
|
|
|
|
|
|
| Connect With Med Device Online: |
|
|
|
