Danish notified body DGM seeks MRA (mutual recognition agreement) CAB (conformity assessment body) status:
This article was originally published in Clinica
Executive Summary
Charlottenlund-based DGM has applied to become a conformity assessment body (CAB) under the EU/US mutual recognition agreement (MRA). The company, a notified body (NB) with DANAK (Danish accreditation) in accordance with EN 45001 and 45012, has CE-marking authority for device and diagnostics under relevant EU Directives, 93/42 and 98/79, respectively. Several EU NBs are interested in becoming CABs (see Clinica No 1002, p 1). DGM's auditors have undertaken the necessary training and now await only the FDA's approval.
You may also be interested in...
California Court’s Inaction On TiO2 Prop 65 First Amendment Case Breeds New Lawsuits
The Personal Care Products Council seeks to stem the rising tide of titanium dioxide Proposition 65 lawsuits, requesting that a California court prohibit the state’s Attorney General and private enforcers from filing and/or prosecuting new suits against cosmetics companies failing to warn about potential TiO2 exposure.
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.