Coenraad Davidsdochter, MSc

Coenraad Davidsdochter, MSc

Team Manager E. Saf. & Software/AI
Senior Consultant

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!'

Before Qserve

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
  • 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. 
Trainer Qualifications: 

Regulatory areas:
EU MDR 2017/745, EU IVDR 2017/746, USA Medical Device Regulations and EU GDPR 2016/0679


- Clinical Evaluation
 - Computer System Validation
 - Quality Management Systems
 - Risk Management 
 - Software - AI, cybersecurity
 - Usability Engineering
 - Health software

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