Team Manager active medical device team
Senior Consultant, El. Saf., Software and AI Expert
Coenraad is a Senior Consultant Software and Artificial Intelligence. With over 20 years of experience in software development of which over 10 years in setting-up, maintaining and improving Quality Management Systems (QMS) based on ISO 13485, MDD 93/42/EEC, MDR 2017/745 and GDPR 2016/679.
He has been responsible for deployment and management of QMS processes, Corrective and Preventive Action (CAPA), Change, Document & Record Control, Management Review, Technical file, Risk Management, Clinical Evaluations and Post Market Surveillance.
Coenraad about working at Qserve
'It is a real pleasure to use my experience and competences to help many companies with their software regulatory and quality challenges. Thank you Qserve for this opportunity!'
Coenraad holds a master’s degree in philosophy of Science, Technology and Society (MSc) with a specialization on Management of technology in society and a Bachelor of Education degree in Mathematics.
Prior to Qserve, Coenraad worked as QA/RA Manager and Program Manager and at a medical device manufacturer for active (software) devices and prior to that as consultant for a Hospital Information System manufacturer.
In these roles, he has covered many areas in software development like design, development, verification and validation testing, clinical evaluation, deployment and maintenance for client-server solutions, cloud systems and apps.
The key expertise areas of Coenraad
Learn more about our services within Regulatory Affairs
- Technical Files. Design, documentation, and review of Technical files for submission to Regulatory Authorities.
- Risk Management. Implementation of Risk Management strategies and fulfill the Risk Manager role per ISO 14971 for various standards; software, IEC 62304, and usability IEC 62366-1.
- Clinical Evaluations. Perform clinical evaluations for software following ISO 14155 and Meddev 2.7/1 rev 4.
- Quality (System) Management. QA/RA management roles. Creating, implementing, maintaining, and improving Quality Management Systems in compliance with ISO 13485 standards, Medical Device Directive 93/42/EEC and EU MDR 2017/745 regulation.
- Information security. Implementing and maintaining process and product requirements for information security according to IEC 27001, cybersecurity, and privacy regulation (GDPR).
- Auditing. Preparing and performing internal ISO 13485 quality system audits as Lead Auditor. MDR gap assessments. Extended experience in preparing and participating as auditee in audits from Notified Bodies.
- CAPA Management. Deploying, managing, and improving Corrective and Preventive Action processes & tools.
- Project & Program Management. Managing Technical File creation, QMS deployment and improvement programs & projects. Prince2 certified.