Services Offered
In the fast-changing world of In Vitro Diagnostics (IVD), I offer specialized consulting services tailored to the unique needs of Start-ups, Scale-ups, Medical Centers, Consultancy Firms, and Advisory Organizations. With a focus on regulatory compliance, improving processes, and strategic support, my hands-on approach ensures smooth navigation through complex regulatory requirements. From setting up compliant processes and creating technical documents to providing expert guidance and practical solutions, my services help clients succeed in the dynamic IVD sector and achieve success in the healthcare field.
Services offered:
- (Guidance in) preparing technical documentation for IVDR
- Assistance with risk management
- (Guidance in) developing procedures for ISO 15189
- Internal (product) audits
- Interim QA and/or QC manager
Start-ups and Scale-ups
For Start-ups and Scale-ups in the IVD sector, understanding regulatory complexities and establishing efficient processes is crucial. I offer expert guidance to ensure compliance and foster growth. My services include internal audits, preparing technical documentation, risk management, and developing ISO 15189 procedures. Additionally, I provide interim QA and QC management and assist in creating customized SOPs and work instructions. [Click here for more information.]
Medical centers
I help Medical Centers enhance their IVD capabilities with services tailored to their needs. I focus on creating technical documentation for in-house testing under ISO 15189, aligning with ISO 13485 standards. My services include gap analysis, establishing compliant processes, implementing risk management systems, developing SOPs, and conducting internal audits. I also offer interim QA and QC management to ensure compliance and identify areas for improvement. [Click here for more information.]
Consultancy & advisory organizations
I provide consultancy firms with additional expertise and temporary capacity to navigate IVD complexities. My services include bridging gaps in technical documentation, preparing IVDR-compliant files, and enhancing risk management processes. I also guide the development of ISO 15189 procedures, conduct internal audits, and offer interim QA/QC management. By working with me, firms can boost their capabilities and better meet client needs in the IVD sector. [Click here for more information.]
Internal Audit Services
I offer expertise in conducting internal audits to ensure regulatory compliance and quality assurance. From product audits to ISO 13485 and ISO 9001 assessments, I provide thorough evaluations to identify areas for improvement and ensure adherence to industry standards. By conducting comprehensive audits, I help organizations maintain regulatory compliance, improve operational efficiency, and enhance overall quality management systems.