Helin Räägel | MDDI

Helin Räägel

Helin Raagel

Consulting Manager, Nelson Laboratories

Helin Räägel, PhD, serves as consulting manager for Nelson Laboratories LLC.

Latest from Helin Raagel

Editorial cartoon showing an explorer deep inside a prehistoric cave, discovering a big book, with the text, %22At last he

Regulatory & Quality

FDA Guidance 2023 on ISO 10993-1: What Changed?FDA Guidance 2023 on ISO 10993-1: What Changed?

byHelin Raagel, Audrey Turley

Oct 10, 2023

11 Min Read

Regulatory & Quality

Complete Rewrite of ISO 10993-1 Creates Industry Buzz Complete Rewrite of ISO 10993-1 Creates Industry Buzz

byHelin Raagel, Thor Rollins

Sep 11, 2023

10 Min Read

All from Helin Raagel

An EU flag, flown by anti-Conservative and anti-Brexit activists, flaps in the air in front of the Elizabeth Tower, commonly

Regulatory & Quality

The Bumpy Road to MDR

The Bumpy Road to MDR

Regulatory & Quality

A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?

A Haystack with No Needle: Is an Extractables Study Appropriate for Limited-Contact Devices?

+1

byHelin Raagel, Matthew Jorgensenand 1 more

Regulatory & Quality

FDA Reclassifies Surgical Staplers and Staples

FDA Reclassifies Surgical Staplers and Staples

The New and Improved ISO 10993-12:2021—What Is Really Changing

The New and Improved ISO 10993-12:2021—What Is Really Changing

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