device sterilization

AdvaMed Warns EPA of Massive Interruption to Patient Care

Leave a Comment / AdvaMed, device sterilization, EPA, ethylene oxide, Medical Device, MedTech, MedTech Economics, Quality/Regulatory / By Inga Hansen

AdvaMed Warns EPA of Massive Interruption to Patient Care In comments filed with the Environment Protection Agency (EPA), industry association AdvaMed called for continued cooperation between the medical device industry and the EPA as the regulations covering medical device sterilization using ethylene oxide (EtO) move forward. AdvaMed said if the proposals are finalized as …

AdvaMed Warns EPA of Massive Interruption to Patient Care Read More »

Contamination Control: Practical Steps to Compliance with EU GMP Annex 1

Leave a Comment / cleanrooms, contaminal control strategy, continuous quality improvement, device sterilization, EU GMP Annex 1, Focus Article, Manufacturing Execution, Medical Device, MedTech, quality assurance, Quality/Regulatory, RC - PLM for Medical Devices, risk management / By Inga Hansen

Contamination Control: Practical Steps to Compliance with EU GMP Annex 1 In August 2022, revised EU GMP Annex 1 requirements related to the Manufacture of Sterile Medicinal Products were issued, starting the clock for compliance. All but one of the new provisions must be fulfilled by August 2023. The updated requirements, designed to protect …

Contamination Control: Practical Steps to Compliance with EU GMP Annex 1 Read More »

MedLance

E-Learning

Moderators

device sterilization

AdvaMed Warns EPA of Massive Interruption to Patient Care

Contamination Control: Practical Steps to Compliance with EU GMP Annex 1

Quick links

MedTech Minds

FDA Courses

Forum
News

About

Contact

Newsletter

Quick Links