Collaboration not confrontation as US device firms learn to comply with design control rules
This article was originally published in Clinica
Executive Summary
FDA inspectors and the medical device companies they are assigned to scrutinise in the US say they are still going through a learning curve on how to comply with the design control rules in the new good manufacturing practice regulation.
You may also be interested in...
Kenvue Breaks Ground On New Headquarters, Appoints Chief Corporate Affairs Officer
Firm hosts groundbreaking for 290,000 square-foot global headquarters it’s having built in Summit, NJ, starting with 100,000 square-foot science and innovation and expected to open in 2025. It announced adding Russell Dyer as chief corporate affairs officer starting 13 March.
Xaira Launches With $1bn-Plus And End-To-End AI Strategy
ARCH and Foresite incubated the company and recruited Genentech R&D veteran Marc Tessier-Lavigne to keep data generation, machine learning research and drug development under one roof.
‘Clear’ Is In The Eye Of The Beholder, New York, CRN Argue In Age-Restricted Sales Litigation
CRN’s request for clarification, as it continues litigating complaint in US District Court for Southern New York, highlights what it contends is vague and overly general language in the legislation passed in October with a 22 April effective date.