SAP PLM Migration for a Global Medical Device Manufacturer

LeverX assisted a medical device manufacturer in migration to SAP and workflow automation.

Client

The client is a leading developer and manufacturer of light-based aesthetic and medical treatment systems. The company produces a diverse range of treatment applications for hair removal, skin revitalization, scar reduction, gynecological health, body contouring, and more.

Challenge

The parent company required the customer to establish a new IT infrastructure and migrate to SAP PLM. Since the company operates in a heavily regulated industry, the new environment had to support strict control processes, traceability, and auditable data management. During the transition, several challenges emerged:

• Complex data migration: Data from multiple legacy systems had to be extracted and consolidated into SAP PLM. Incomplete mapping and documentation created gaps in the migration plan, and around 25% of critical data was identified only two months before go-live.
• Strict compliance requirements: The solution needed strong record control and audit readiness to meet FDA standards and withstand government audits.
• Process flexibility: The system had to accommodate regulation-driven workflows while maintaining structured SAP processes.
• User adoption: Employees faced a steep learning curve as they transitioned from familiar legacy tools to SAP, and initially did not understand the necessity for the migration.

Solution

LeverX partnered with another SAP integrator to execute a phased migration. LeverX led the implementation and tailoring of SAP Product Lifecycle Management (SAP PLM), while the partner managed the base ERP migration.

Our team delivered a compliant, digitized engineering and quality management environment by:

• Establishing standardized PLM processes for materials, documents, BOM governance, and engineering change control
• Digitizing regulated quality workflows (including CAPA, supplier corrective actions, and deviation handling) to improve traceability and audit readiness
• Automating critical migration and setup activities to reduce manual effort and accelerate go-live execution
• Converting paper-based documentation into controlled electronic records with approval workflows aligned to compliance requirements

Technology Stack

• PLM platform: SAP PLM
  Foundation for engineering lifecycle processes, including materials, documents, BOMs, and engineering changes.
• Workflow orchestration: Integrated Process Solution (IPS)
  Configurable workflows supporting regulated, end-to-end process execution.
• Material master and BOM automation: BOM/Material Master Extension & Allocation Tool (BMAX)
  Automation for material master setup, BOM migration, and required data extensions.
• Data migration: Velox
  Extraction and consolidation of data from multiple legacy sources into SAP PLM.
• Document digitization and approvals: Cideon Conversion Engine
  Conversion of paper documentation into PDFs and the enablement of electronic approvals.

Results

LeverX successfully consolidated multiple legacy systems into a single SAP-based environment, simplifying process management and reducing maintenance and support costs. The new system enabled:

• Centralized control of engineering, quality, and compliance data
• Transition to electronic documentation and digital approval workflows
• Elimination of manual handling and paper-based processes
• Readiness for Phase 2 expansion with advanced reporting and governance guardrails
• Improved efficiency and transparency across product lifecycle processes