Current regulatory news

ISO 13485 and ISO 9001 renewed at Eagle Stainless Tube & Fabrication

Eagle Stainless Tube & Fabrication had its ISO 13485:2016 and ISO 9001:2015 quality management certifications renewed. Eagle has been maintaining ISO quality certifications since 1998.

ISO 13485 and ISO 9001 are internationally recognized standards setting requirements for the development, production, and distribution of medical devices. By adhering to this rigorous specification, Eagle Stainless ensures its products and services consistently meet customers’ stringent requirements.

“We’re thrilled to have again successfully renewed our ISO certifications,” says Robert J Bubencik Jr., VP operations.

ISO 13485 certification demonstrates Eagle Stainless Tube’s ability to consistently provide medical devices and services that meet our customer requirements and expectations.

https://www.eagletube.com

Preparing medical device manufacturers for upcoming changes to regulations

Medcrypt Inc.’s FDA Cybersecurity Readiness Services helps medical device manufacturers (MDMs) navigate the U.S. Food and Drug Administration’s (FDA) Refuse to Accept (RTA) policy and the new Section 524B requirements stemming from the Consolidated Appropriations Act, 2023.

The RTA policy evaluates the acceptability of medical device submissions, focusing on crucial elements, including cybersecurity, and may result in refusal if requirements from the amendment of the Food, Drug, and Cosmetic Act (FD&C Act) aren’t met. Medcrypt’s services prioritize the FDA’s eSTAR, a now mandatory FDA program guiding manufacturers in documenting and describing to the FDA their cybersecurity efforts for all 510(k) submissions, unless exempted. Both initiatives were issued by the FDA with an effective date of Oct. 1, 2023.

Medcrypt’s FDA Cybersecurity Readiness Services streamline MDMs’ FDA journey, catering to those preparing, submitting, or already encountering issues.