Consulting, coaching and hands-on support in complex, regulated development environments — more than 25 years of experience across medical technology, pharma, public administration and finance.
Portalmind — Agile. Quality. Compliance.
One profile that unites what usually stays separate
The focus is on introducing, adapting and safeguarding agile processes within existing quality and compliance requirements — FDA, MDR, GxP, MaRisk, ISO and BSI.
Service portfolio
From the agile organisation and compliantly implemented AI to demonstrable control across the entire product lifecycle.
Introducing and coaching SCRUM, SAFe® and Kanban — including scaling across multiple teams (RTE, SoS) and coaching Scrum Masters, Product Owners and leaders.
Introducing AI in regulated environments — with design controls, validation, human-in-the-loop and a predetermined change strategy (PCCP). AI assists; humans remain accountable.
Data integrity per GxP/GDP and ALCOA+ as the foundation of trustworthy AI: robust data, governance and traceability, plus eLearnings on data integrity and GMP/GDP.
The shift from a static design history to a living AI compliance history: robust processes (Lean Validation), audit preparation, CAPA management and SOPs — continuously controlled.
Training concepts, curriculum development and programmes for operational teams and leaders — from FDA, MDR and ISO 13485 to GAMP5, delivered through interactive eLearnings.
Project steering and qualification in defence programmes: from C4ISR systems and CONOPS development to training and exercise environments (Trainex) and combat simulation.
Agile transformation, IT-related project steering (TeamCenter, Polarion, Azure DevOps) or IT security management (BSI, MaRisk) — let's talk about your context.
References & industries
Selected organisations in whose environment Portalmind has delivered consulting, coaching and implementation projects.
Affiliated / Technology partner
Portalmind brings the regulatory and methodological consulting — MINGRAI® the technology: a Semantic Lifecycle System built on knowledge-graph technology that connects strategy and operational execution.
Knowledge states, processes, dependencies and decisions stay connected and traceable across the entire lifecycle — exactly the foundation on which a static design history becomes a living compliance history.
MINGRAI® — A solution built on knowledge and experience.
Expertise profile (excerpt)
SAFe® Program Consultant · PMP · ITIL · COBIT
SCRUM · SAFe® · Lean · DevOps · Design Thinking · FMEA
TeamCenter · Polarion · JIRA · Windchill · Azure DevOps · Captivate · MS Project · SharePoint · Fusion360
GxP (CFR/MDR) · GAMP5 · ISO 9001 · ISO 13485 · ISO 14971 · ISO 27001/27002 · MaRisk · BSI 100-1…4 · BaFin
Whether agile scaling, compliantly implemented AI or a robust compliance lifecycle management — Portalmind supports you from strategy to operations.