Medical Centers.

For Medical Centers seeking to enhance their capabilities in the IVD sector, my services are tailored to support their unique needs. With a focus on enabling the creation of technical documentation for in-house testing under the ISO 15189 standard (IVDR Article 5, paragraph 5), I aim to facilitate their scientific and diagnostic objectives.
I offer a comprehensive gap analysis to determine any missing processes, aligning with ISO 13485 standards, and strategize the most efficient way to address them. This includes establishing compliant processes, implementing robust risk management systems, and guiding the development of technical documentation. I also provide assistance in creating tailored Standard Operating Procedures (SOPs) and work instructions, ensuring clarity and efficiency in daily operations.
Furthermore, I conduct internal (product) audits to ensure compliance and identify areas for improvement. As an interim QA and/or QC manager, I can provide expert oversight and support, ensuring your quality systems are effective and compliant.
By providing expert guidance and practical solutions, I empower medical centers to excel in their vital contributions to healthcare, ensuring they achieve regulatory compliance while maximizing their impact in patient care..