Jan 1, 2020 | Ask the Expert, EASeNews
In this month’s Ask the Expert column, we thought we’d start this new year by taking the opportunity to humbly share why we at EAS are confident that our staff and consultants offer the best expert regulatory knowledge in the industry, providing proactive and accurate...
Oct 17, 2019 | EAS in Action, EASeNews, Medical Devices
Medical device manufacturers have a new tool available to demonstrate substantial equivalence through FDA’s 510(k) Safety and Performance measures. In a recently released Final Guidance, the Agency, as part of their effort towards stimulating innovation and reducing...
Oct 17, 2019 | Did You Know, EASeNews, Medical Devices
Quality Management Systems (QMS) for medical devices are cumbersome as layers upon layers of critical checks ensure the safety and effectiveness required for the consumer. However, in an effort to reduce overly burdensome recordkeeping processes FDA has announced a...
Oct 1, 2019 | Drugs, EAS in Action, EASeNews
Bryan Coleman, Senior Director for Drugs and Medical Devices, and Robert Fish, Independent Advisor for Quality and Compliance will be at the EAS booth, #524, at the International Society of Pharmaceutical Engineers Annual Meeting and Expo October 27-29, 2019 in Las...
Sep 1, 2018 | Drugs, Issue of the Month
By James Evans, EAS Independent Consultant FDA has been implementing the Safety and Innovation Act since it was passed by Congress in 2012. The Act requires FDA to establish Mutual Recognition Agreements (MRAs) which are agreements between two or more countries to...
