Profile
| Username | MMahoney |
| First Name | Michelle |
| Last Name | Mahoney |
| Title | Quality & Regulatory Strategist | MedTech Growth Partner |
| Location | Shrewsbury, MA, USA |
| Professional Bio/Service Description | I’ve spent the past 17+ years in medtech helping teams bring their ideas from concept to commercialization. Along the way, I’ve built and scaled quality systems, navigated FDA and international regulations, and supported launches that made a real impact for patients. What I love most is working side-by-side with founders, executives, and growing teams to solve the challenges that come with building something new. Whether it’s:
I focus on practical, actionable solutions that move the business forward. I’ve partnered with startups and established manufacturers alike, and I understand the balancing act between compliance, innovation, and growth. My goal is always to make quality and regulatory work for the business—not against it. If you’re building something meaningful in medtech and need someone who can jump in, simplify the complex, and help align quality with your big-picture goals, that’s where I can add value. |
| LinkedIn URL | |
| Languages | English |
Expertise
| Years of MedTech Experience | 17 |
| Licenses and Certifications | Certified Biomedical Auditor, Six Sigma Green Belt, Lead Auditor – ISO 13485; 21 CFR 820 Compliance |
| Areas of Expertise | Quality Assurance, Quality Control, Good Manufacturing Practice (GMP), Data Analysis, Product Development, Risk Management, Compliance & Auditing |
| Regions of Expertise | United States (US), European Union (EU), Canada, United Kingdom (UK), Australia, Japan |
| Service Provided | Consulting |