About

About

About QRcompliance

QRcompliance is a consultancy specialized in Quality Management Systems for the (in vitro diagnostics) medical device industry. The purpose of QRcompliance is to support professionals working in the field of (IVD) medical devices, to comply to the law and regulations which are in force to safeguard patient safety.

I have a wide professional experience including diagnostic assay development, process validation, quality system implementation and regulatory affairs.

After the completion of the bachelor study “medical biotechnology”, I have worked, for more than 20 years,  for several companies, operating in the field of in vitro diagnostic medical devices and pharmacy. In 2011, I made the switch from product development to the position as Quality Manager. In this role, as part of the management team, I was final responsible for the compliance of the Quality Management System (QMS) against the  ISO13485 / 21CFR820 and the compliance of the technical files of in vitro diagnostic products against the legal requirements (EU, UK and US).

Miranda Sieswerda

Founder and CEO