LENDI Consulting GmbH

At LENDI Consulting GmbH, we support medical device manufacturers with expert solutions in sterilization processes and quality management systems (ISO 13485). Our services include: Planning, execution, and documentation of sterilization validations (PQ) and product monitoring GAP assessments of existing documentation and ISO standards to identify compliance gaps and improvement opportunities Support for worldwide regulatory submissions related to sterilization and responses to authority questions Coordination with external laboratories and sterilization service providers Review and optimization of technical documentation and worst-case product family selections Leadership and support in QMS audits, CAPA investigations, and continuous process improvements By combining technical precision with regulatory insight, we help our clients establish compliant, efficient, and science-based sterilization processes that meet international standards.

• Employees 1
• Founded 2023