Karen has been with Lamellar since August 2010 and has established our Quality and Business Administrative systems. These systems have been adapted, over recent years, to match the growth in size and complexity of Lamellar and ensure compliant and efficient operations. She is responsible for the Management of internal and external audits as well as supplier qualification and oversight. Karen’s other responsibilities include Lamellar’s information systems including data archiving.
From 2013 to 2018, Karen set-up and managed Lamellar’s ISO 13485:2003 and ISO 9001:2008 accreditations, which successfully underwent several routine audits by our Notified Body. She also oversaw Lamellar’s CE device accreditation program for two different medical device applications and the Quality compliance of the clinical supplies for Lamellar’s clinical studies.