Liferaft helps medical device companies bring innovative products to market and keep them there.
Services
- QMS Audits and Gap Assessments: Prepare for regulatory audits with confidence. We conduct internal audits, mock inspections, and gap assessments to help you meet 21 CFR 820 (QSR/QMSR), ISO 13485, and EU MDR requirements - reducing risk, avoiding findings, and strengthening your QMS.
- QA/RA & Product Development Support: Expert support when you need it. From design controls and risk management to CAPA and supplier quality, we provide on-demand expertise to strengthen your product development and quality systems, without the need for full-time staff.
- Coaching & Training: Engaging, hands-on guidance in best practices. We provide expert training in design controls, risk management, supplier management, verification & validation, CAPA and root cause analysis… along with other key quality and compliance areas to help your team stay audit-ready and efficient.
Contact
Email: [email protected]
Phone: 267.730.3202
About
I’m a mechanical engineer turned regulatory and quality expert. With hands-on experience in R&D, Quality, and Regulatory, I love helping companies navigate FDA, ISO 13485, and EU MDR requirements with confidence. Whether it’s building robust processes, preparing for audits, or solving compliance challenges, I bring a practical, energetic, engineering-driven approach to QA/RA.
- 15 Years of Engineering Experience: Engineering professional since 2010, with a specialized focus on medical devices since 2012. Extensive background in medical device design, risk management, quality systems, and regulatory compliance across various product types. I have worked with over 100 medical device companies, from startups to global enterprises.
- Regulatory Affairs Certification (RAC) – RAPS: Certified by the Regulatory Affairs Professionals Society (RAPS), demonstrating expertise in global medical device regulations, including FDA, ISO 13485, and EU MDR.
- Certified Lead Auditor (Exemplar Global/CQI & IRCA): Certified by Exemplar Global and CQI & IRCA, qualified to conduct audits against ISO 13485 and EU MDR (2017/745).
- Bachelor of Science in Mechanical Engineering (BSME): Strong foundation in product design, development, and engineering principles.