Hadar Friedman | Quality, validation and regulatory consulting for medical devices and pharma
I accompany organizations and startups in medical devices and pharma in building quality capabilities that hold up in the field: validations, QMS, professional training, training of quality employees, readiness for audits, and process improvement in a practical way that respects the reality of time, people, and resources.

I work using the BOOST method - a methodology that I developed and that accompanies me in every project: First, we address what creates real regulatory/business exposure, clean up everything that does not serve production and the business (repetitive operations, duplication, waste on the production line, etc.), build workflow routines and documentation that will remain even after the project is over, and then expand the method to additional processes step by step, creating a single system that speaks the same language.

I'm a tech enthusiast and a people person, driven by the synergy between the two.
eQMS tools, automations, computerized systems and AI can save time and reduce errors, but only if they are built around the right process and the right behavior. With the QABOOST method, I will teach you to write prompts and create agents that work alongside us, undergo validation and allow the system to breathe. I can test eQMS systems for you according to your organization's needs and accompany the implementation from end to end.
In my projects you will see a combination of:

Structure and standardization (templates, flows, traceability requirements)

Implementation and team management (how we really work on a daily basis, not just how we “should”)

Management metrics and routines that allow management to see the picture and make decisions quickly

What will it look like when I arrive at your organization? I probably won't be in a conference room for long.
You will see me in the field walking around production, talking to QA, engineering, operators, warehouse and purchasing, and checking how things really happen.
Because in the end:
Audit findings come from the gap between “written” and “implemented”
I build solutions that respect those who work on the line, and connect what the regulation requires with what the organization is able to sustain over the long term.
I work closely with teams (QA/RA/Operations/Engineering/IT) and translate regulatory requirements into daily implementation, avoiding excess bureaucracy.
Working with me doesn’t stay “on paper.” The goal is a single system that works in the same language: clear documentation, routines that run the organization, and risk-based decision-making so you can grow, enter markets, and deal with criticism without drama.