Support for QA activities such as release management, deviation handling, and quality assurance in projects. Tailored to your needs, ranging from temporary support to long-term assignments.

Support in building, implementing, and further developing quality management systems (QMS/eQMS) that meet regulatory requirements and function effectively within the organization. Includes customization, certification, and liaison with regulatory authorities.

Conducting internal audits, supplier assessments, and providing support for regulatory inspections. Experience with regulatory frameworks such as GxP, MDR, IVDR, CFR, and MDSAP.

Validation of computerized systems to ensure reliability, traceability, and regulatory compliance in accordance with applicable regulations and guidelines, such as GAMP.

Validation of processes and analytical methods to ensure quality, reproducibility, and compliance with regulatory requirements.

Validation of equipment and production environments to ensure stable and controlled production.

Support in the development of technical documentation tailored to the intended use, risk class, and regulatory requirements. Includes clinical evaluation as well as product safety and testing.

Market Access support, ranging from regulatory strategy and submissions to approval, renewal, and compliance in global markets.

We help healthcare organizations translate regulatory requirements into effective work practices. With our experience in regulations such as the MDR and IVDR, we create structure, reduce risk, and ensure that processes work in practice.

Plantvision various types of support and service agreements to provide ongoing assistance with both operation and management.

Plantvision various types of support and service agreements to provide ongoing assistance with both operation and management.