Struggling with regulatory hurdles, audit readiness, or quality issues? I deliver pragmatic, hands-on support to get your MedTech or healthtech company back on track—fast. - Rapid assessment and remediation of QMS, DHF, or audit findings - FDA, CE, ISO 13485 compliance roadmaps - Process optimization and documentation - Stakeholder training, project rescue, and team alignment Ideal for companies facing critical deadlines, market access challenges, or scaling quality systems. Results-focused, no-nonsense support for regulated success.