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About Qwadrant Consultancy

My name is Liesbeth Plompen-Alberts. My company, Qwadrant Consultancy, can help with ISO 9001 and ISO 13485 certifications and with regulatory compliance for medical devices. I am experienced with creating, maintaining and improving quality management systems in compliance with ISO 9001, ISO 13485, ISO 14971, IEC 62304, FDA 21 CFR part 820 and EU Medical Device Regulation 2017/745. I have a demonstrated history of working in the medical device industry, specifically in quality assurance, regulatory affairs and clinical investigations. 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.

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