Thoughts To Inspire

How to Build a One-Person ISO Consulting Business in 2026?

26 Jul Each minute of our life is a lesson but most of us fail to read it. I thought I would just add my daily lessons and the lessons that I learned by seeing the people around here. So it may be useful for you and as memories for me.

1. Is the Intended Use Clearly Defined?

Everything begins here. If your intended use is vague, your regulatory pathway becomes equally unclear.

2. Have You Identified and Controlled Risks?

No medical device is risk-free. The expectation isn’t zero risk. The expectation is that risks have been systematically identified, evaluated, mitigated, and monitored throughout the product lifecycle. Risk management isn’t just another document. It’s a design activity.

3. Can Every Requirement Be Traced?

One feature. One requirement. One verification. One result. That traceability should exist throughout the entire development lifecycle. Without traceability, demonstrating compliance becomes significantly harder.

4. Have You Proven the Software Works?

Testing is far more than checking whether the application runs. Verification demonstrates that requirements have been implemented correctly. Validation demonstrates that the software actually meets user needs within its intended clinical environment. Both are equally important.