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Pharma & Life Sciences
augusti 27, 2026
Launching a Medical Device in the US? Start With These Four Steps
Being ISO 13485 certified doesn't automatically make you FDA-inspection-ready. It gets you close, but the two frameworks are not a one-to-one match, and the...
Thomas Van Dorpe
Business Applications
Pharma & Life Sciences
augusti 27, 2026
Why your CE mark won't get you onto the US Market
For many European medical device companies, the US represents the next growth market. The surprise comes when they discover thata CE mark, established quality...
Thomas Van Dorpe
Business Applications
Pharma & Life Sciences
augusti 27, 2026
AI in medical devices: What the FDA's predetermined change control plan actually covers
Your medical device's AI algorithm will not stay the same after it reaches the market. It will be retrained, refined, and improved, and every one of those...
Thomas Van Dorpe
Business Applications
Pharma & Life Sciences
maj 06, 2026
Why AI belongs on the Pharma C-level strategic agenda
Artificial intelligence is no longer a future technology for pharma; it is already part of the infrastructure that supports scientific progress, operational...
Florin Gainar
Business Applications
Pharma & Life Sciences
maj 06, 2026
EU GMP Annex 11 & Annex 22: The New Compliance Reality for AI in Pharma
Pharma is in the middle of its biggest regulatory shift in more than 30 years. And for the first time, regulators are directly addressing AI, with its own...
Thomas Van Dorpe
Business Applications
Pharma & Life Sciences
maj 06, 2026
What Pharma Can (and Cannot) Do with AI Under Annex 22
The business wants AI agents, the use cases look compelling, and the technology is moving faster than anyone can comfortably track, and then somewhere in the...
Thomas Van Dorpe
Business Applications
Pharma & Life Sciences
maj 06, 2026
Who Owns AI in Pharma? Why Governance Must Be Cross‑Functional
Most pharma AI initiatives do not fail because the technology does not work. They fail because no one can clearly answer a much more basic question: Who owns...
Thomas Van Dorpe
Business Applications
ERP
maj 05, 2026
Autonomous AI Agents in Dynamics 365: Your First Line of Intelligent Automation
Imagine intelligent digital colleagues that work proactively and learn from user feedback; designed to automate repetitive tasks, reduce errors and give your...
Thomas Van Dorpe
Business Applications
ERP
maj 05, 2026
ERP in 2026: Turning Point and Success Factors for Your Organization
Why 2026 is the ultimate moment to act Are you still hesitating about an ERP decision? Then 2026 is the year in which you can no longer afford to wait. The...
Thomas Van Dorpe
Business Applications
ERP
maj 05, 2026
ERP selection: why choosing the right partner is just as important | Advice from selection experts
Choosing an ERP platform is just the beginning. The implementation partner largely determines whether your project will be a success. The wrong choice can lead...
Thomas Van Dorpe