Life Sciences | AssurX

EUDAMED Update: What You Need to Know Now

Sal Lucido2022-06-30T21:11:53+00:00June 30th, 2022|

The European Union (EU) Medical Device Regulation (MDR) officially went into effect in May 2021, while the In-Vitro Devi [...]

Tracy Orlick2025-10-03T04:02:53+00:00June 23rd, 2022|

Morgan Hill, CA., June 22, 2022 — AssurX, Inc. (AssurX), a leader in quality management and regulatory compliance softwa [...]

Sal Lucido2024-06-03T13:58:34+00:00June 21st, 2022|

In the life science industry, adjustments are a necessary element throughout the product lifecycle. From R&D through [...]

Sal Lucido2024-12-31T23:16:11+00:00May 26th, 2022|

EU Medical Device Regulation (MDR) has been in effect for almost a year. As anticipated, the regulation has proven to be [...]

Sal Lucido2024-06-25T18:25:29+00:00May 17th, 2022|

In recent months, the U.S. Food and Drug Administration (FDA) has issued a dozen warning letters over Foreign Supplier V [...]

AssurX Blog2025-01-10T20:52:36+00:00May 5th, 2022|

This is the second installment of a two-part series focusing on the importance of a quality management review for compa [...]