Risk Management Doesn’t Have to Hurt — It Has to Happen Early
If risk management feels like a burden, you’re probably doing it too late. Let’s be honest.Risk management is often seen as the slow, painful part of medical product development.An obligation….
Discipline Is Not a Checklist
Discipline Is Not a Checklist: Milestones Must Serve the Work — Not the Other Way AroundIn diagnostics and medical devices, we love structure.Milestones. Deadlines. Stage gates. Design freezes. They give…
The Requirements Are Late — And So Is Your Product
Why Skipping User Needs Turns Innovation into Imitation Let’s cut to the chase: If you’re writing requirements after the prototype is done, you’re not managing — you’re documenting failure. At…
CE Mark ≠ Success
CE Mark ≠ Success: Why Regulatory Approval is Just the Beginning A diagnostic product gets its CE mark. The press release goes out. The team celebrates. And six months later,…
Why Most Diagnostic Innovations Fail — And What No One Talks About
“The science worked. The prototype worked. The team was brilliant. And still, the product never made it.” We’ve heard this story too many times. At 2B Consulting, we’ve lived it…
2B – IPR
It’s our very own IPR ANTHEM! Protect the spark. Defend the flame.Ideas matter — we own the game. From invention’s core to claim and scope,We draft the vision, map the…
2B – Consultancy!
It’s our very own CORPORATE ANTHEM! From Finland to the DACH domainInnovation’s running in our veinPrecision. Vision. Trademark game—Let’s go. IP strong like fortress walls,Patents rise when strategy callsFrom nucleic…
AQAP-2110 GPT
If you use ChatGPT (responsibly…), you’re welcome to try our “AQAP Compliance Coach“, the comprehensive AQAP-2110/2131 compliance coach, sparring partner, document reviewer, and audit simulator. Oh and what is AQAP-2110?…