Frequently asked questions
The questions companies ask most often before we start working together.
Working with me
Software, AI and PRRC
No questions match your search.
Standards and audits
Book a 30-minute call and ask me directly.
Didn't find an answer?
What exactly do you do?
I serve as the quality and regulatory manager for medical device companies, or work alongside the QA/RA manager you already have. I build or improve the quality system, take the product through to registration, and stay with you afterwards. I also take on defined projects, such as PMS, audits, remediation and regulatory changes.
Do you work with companies outside Israel?
Yes. Most of my work is remote. When a project needs me on site, we plan it together.
How do engagements typically work – project-based or ongoing?
Both are possible. Many clients start with a project and continue with a few hours a month of ongoing support. I work by the hour, and offer a fixed price only when the scope is closed and known in advance.
Do you work with software and AI-based medical devices?
Yes. I work with software as a medical device and devices with software, including AI-enabled devices, under IEC 62304, IEC 82304-1, EU MDR and the EU AI Act. Cybersecurity is outside my scope.
Do you work with early-stage companies that don't have a QMS yet?
Yes. I come with a quality system I built that already meets the regulatory requirements, and I adapt it to your company and the way you work. You don't start from a blank page.
Can you support an existing team, or only work as the sole QA/RA resource?
Both. I can be your QA/RA manager, or work alongside the QA/RA manager and team you already have.
Which regulatory frameworks do you work with?
ISO 13485, EU MDR, EU IVDR, FDA QMSR (21 CFR Part 820), MDSAP, ISO 14971 for risk management and IEC 62304 for medical device software.
Can you help us get ISO 13485 certified?
Yes. I build or upgrade the quality system, run internal audits and prepare your team for the certification audit. The certificate itself is issued by an accredited certification body.
We're moving from MDD to EU MDR. Can you help?
Yes. I align the quality system and the technical documentation with MDR, update PMS and vigilance, and prepare you for the notified body audit.
What types of audits do you support?
Notified body audits, FDA inspections, MDSAP audits and customer audits. I prepare your team, run internal and mock audits, and support you during the audit itself.
Can you conduct supplier audits?
Yes, remote or on site, with a full report of findings and recommended follow-up.
What happens after an audit finding or an FDA warning letter?
I analyze the findings, build the corrective action plan and the documentation that supports it, and help you respond on time. For a 483 or a warning letter, I map the gaps and lead the remediation plan.
How much does it cost?
It depends on the scope. I work by the hour, and after a first conversation I send a proposal with the scope, estimated hours and timeline. Sometimes I need to look at what you already have before I send the proposal.
Can you serve as our PRRC?
No. I don't take on the PRRC role under EU MDR Article 15 as an outside person. I work with the PRRC you appoint and make sure they have what they need to do the job.
Can we use AI tools in our quality system?
Yes, with control. I help you write the procedure for using AI, validate the tools you use and train your team, so the AI supports your work without creating new risks.
Can you audit a quality system you built for us?
No. If I built your quality system, or ran it as your quality manager, I don't run its internal audit, so the audit stays objective and independent. I bring in an external auditor you approve in advance.