Your quality & compliance specialist

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 First 

Looking for an effective & efficient quality management system?

Qwadrant Consultancy can help with:

• ISO 9001 certification
• ISO 13485 certification
• Internal and external audits

Regulatory Compliance 

Need help with your technical documentation?

Qwadrant Consultancy is specialized in medical device regulations. The following services can be offered:

• Help with CE marking
• Creation of technical documentation
•  Expedited market access