About Qwadrant Consultancy

“A quadrant is one of the four equal parts of a circle, divided by two perpendicular lines”

Quality is a vital part of every company, but it is often difficult to navigate through the vast amount of rules and regulations. Qwadrant Consultancy strongly beliefs in developing lean processes that match the purpose and objective of your company, so that you can focus on what you do best. I can help in setting up or improving your quality management system and creating technical documentation for your products. I can also perform internal audits or assist with audits from your notified body or competent authority. Whether it is setting up a small quality management system, tailored for your company, or bringing your class I, II or III medical device to the market, we will find a solution that best fits your need. 

After completing my MSc in Biomedical Sciences at Maastricht University, I have worked in medical device and pharmaceutical companies for over 10 years. I started in project management of clinical investigations, where I completed multiple international clinical trials on class III medical devices. Afterwards, I worked as an ISO 9001 certified lead auditor for a few years, performing global project, process and external site audits to ensure compliance with internal and external requirements. I also worked as a clinical research associate for pharmaceutical clinical trials, where I was responsible for performing site qualification, site initiation, interim monitoring, and close-out visits ensuring regulatory and protocol compliance.  

I returned to the medical device industry in 2018, where I have been working as a Quality and Regulatory Manager, responsible for maintaining and improving the quality management system for Class I and IIa medical devices in compliance with ISO 13485, ISO 14971, IEC 60601, IEC 62304, 21 CFR part 820 and EU Medical Device Regulation 2017/745. In this role, I was responsible for product conformity and maintenance of technical documentation. I also served as the liaison with the notified body and competent authorities. I performed internal and external audits and was responsible for conducting company-wide training on QMS and regulatory requirements. I was the management representative and person responsible for regulatory compliance (PRRC). 

In 2022, I started Qwadrant Consultancy and became a quality and regulatory consultant. Over the past years, I have been able to successfully grow my network, which now includes experts on many areas, including medical device software development, IEC 60601, risk management and representatives of notified bodies. Contact me to find out if my approach to quality and regulatory compliance can benefit your company.