How I can help
I work as your QA/RA manager or alongside the one you already have, and I take on defined projects.
QMS setup and upgrade
Regulatory strategy, technical documentation and registration
Software and SaMD
Risk management and CAPA
PMS and vigilance
Audits
Remediation after a notified body audit, FDA 483 or warning letter
Regulatory change projects
Change control and ECOs
Controlled use of AI in the QMS
Training and mentoring
As your QA/RA manager, or alongside the one you have. Also when your QA/RA manager is away for a while.
Ongoing QA/RA
Projects
A 30-minute call. You tell me where you are, I tell you what I'd do first and whether I'm the right fit.