ISO 13485 Expert in Medical Device & IVD Device Quality Systems
Regulatory and ISO 13485 Expertise Behind ReadySet
ReadySet is built on extensive hands-on experience in ISO 13485 quality management systems, regulatory affairs, and medical device compliance. This expertise comes from decades of supporting MedTech companies in building compliant and efficient QMS frameworks.
About the ISO 13485 Expert
ReadySet is developed by Donat De Groote, founder and managing director of AZ Biotech Consulting.
With more than 40 years of experience in biotechnology, regulatory affairs, and quality management, he has worked with a wide range of organizations from early-stage startups to established companies.
His work has focused on helping organizations build robust quality systems, prepare regulatory submissions, and successfully navigate certification and compliance processes.
Areas of ISO 13485 and Regulatory Expertise
ISO 13485 Quality Management Systems
Extensive experience in the design and implementation of ISO 13485 compliant quality management systems, including:
- QMS architecture and process structuring
- SOP development and documentation frameworks
- audit preparation and regulatory inspections
- quality system implementation for growing MedTech companies
Regulatory Affairs for Medical Devices (MDR & IVDR)
Support for companies navigating complex regulatory environments including:
- EU Medical Device Regulation (MDR)
- In Vitro Diagnostic Regulation (IVDR)
- CE marking strategies
- regulatory documentation and compliance planning
Technical Documentation
Experience in structuring and preparing technical documentation required for regulatory approval, including:
- Design History Files (DHF)
- Device Master Records (DMR)
- Technical Files and regulatory submissions
- documentation frameworks aligned with regulatory expectations
Support for MedTech organizations
Advisory and operational support for companies developing medical devices, diagnostics, and regulated technologies, including:
- regulatory strategy
- quality system implementation
- compliance readiness
- support during certification and regulatory interactions
As an ISO 13485 expert, AZ Biotech Consulting supports companies in achieving regulatory compliance and building robust quality systems.
Why This ISO 13485 Expertise Matters for ReadySet
ReadySet is not a generic documentation template.
It is a structured QMS framework derived from real-world regulatory and quality management experience.
The architecture of ReadySet reflects practical experience in:
- building quality systems from the ground up
- structuring technical documentation
- preparing organizations for audits and certification
- ensuring alignment with ISO 13485, MDR, IVDR, and software standards such as IEC 62304
This experience ensures that ReadySet provides a practical and regulatory-aligned foundation for MedTech quality systems.
Education and background
- PhD in Sciences, specialization in Immunology
- Master’s Degree in Biology
- Postgraduate Diploma in Management