Start-ups and Scale-ups.

For Start-ups and Scale-ups venturing into or rapidly expanding within the IVD sector, navigating regulatory complexities and establishing efficient processes are crucial. With my hands-on, pragmatic approach, I offer expert guidance to ensure compliance and foster growth. From R&D to market launch, I specialize in setting up the processes needed for IVDR compliance. This includes conducting internal (product) audits to ensure all aspects of your IVD products meet regulatory standards and guiding you in preparing comprehensive technical documentation for IVDR.
I provide assistance with risk management, helping to identify and mitigate potential issues early in the development process. Additionally, I offer guidance in developing procedures for ISO 15189, ensuring your laboratory meets the highest standards for quality and competence. As an interim QA and/or QC manager, I can provide expert oversight to ensure your quality systems are effective and compliant.
Furthermore, I assist in creating efficient Standard Operating Procedures (SOPs) and work instructions, complete with clear templates tailored to your specific needs. By crafting customized templates, I simplify the regulatory documentation process, paving the way for successful product launches and sustained growth.