About us
Immediate impact
to your organization.
Who We Are
Tech2Med is a professional services organization specializing in providing top Regulatory, Quality and R&D experts to clients across the medical device and IVD industry. Our highly experienced professionals come to you with 10+ years of experience in their respective fields. This allows them to jump in and make an immediate impact to your project and organization.
Our commitment
to our partners
We understand what you need because we have all worked in a medical device or IVD corporate setting. We know how to work in large and small companies, how to scope projects with an eye towards budget, and pride ourselves in identifying the right resource to execute your project correctly.
Owner
Kelli Anderson
Co-Owner and Principal ConsultantM.S. Regulatory Science, RAC (US & EU)
Kelli has 25+ years of regulatory and compliance experience spanning orthopedics, active implantables, computer assisted surgery, and imaging devices. She has authored numerous 510(k)s, PMA supplements, Annual Reports, EU Technical Files, Design Dossiers and Health Canada License Applications. In addition to regulatory responsibilities, she has participated in FDA/NB/PMDA audits running both front room and back room activities, coordinated recall tracking, CAPA investigations and close- out activities, filed MDR/Vigilance reports and assisted with 483 responses. Kelli is able to build strong cross-functional relationships within an organization and with governing bodies.
Owner
David Anderson
Co-Owner and Principal Consultant
B.S. – Mechanical Engineering
David has 20 years of product development experience, 8 years of experience authoring numerous 510(k) submissions and conducted technical file remediation for EU MDD compliance and MDR transitions. David has been the lead engineer, from concept to market release, for numerous medical devices including orthopedic implants (trauma, knee, foot & ankle), surgical power tools and surgical instruments. In his engineering management role for a small start-up company, David was also responsible for quality system activities, manufacturing vendor management and qualifications, sterile product validations and EU regulatory compliance.
Owner
David Anderson
Co-Owner and Principal Consultant
B.S. – Mechanical Engineering
David has 20 years of product development experience, 8 years of experience authoring numerous 510(k) submissions and conducted technical file remediation for EU MDD compliance and MDR transitions. David has been the lead engineer, from concept to market release, for numerous medical devices including orthopedic implants (trauma, knee, foot & ankle), surgical power tools and surgical instruments. In his engineering management role for a small start-up company, David was also responsible for quality system activities, manufacturing vendor management and qualifications, sterile product validations and EU regulatory compliance.
Case Studies
Accelerating Compliance and Innovation
Orthopedic Device
Manufacturer >
FDA Regulatory Strategy | 510(k) Submissions | Orthopedic Devices | Labeling & Biocompatibility Support
Fortune 500 Medical
Device Manufacturer >
Global Regulatory Support | Manufacturing Site Transfers | Regulatory Staffing | Change Management
Startup Cardiovascular
Medical Device >
FDA 510(k) Remediation | Regulatory & Clinical Leadership | Quality Systems Support | Startup Advisory
Your Product Our Experience
Partnering with Tech2Med means bringing top-tier Regulatory, R&D, and Quality experts directly to your team. With decades of hands-on medical device and IVD experience, we jump in fast, solve complex challenges, and ensure your projects stay on track, compliant, and ready for market. Think of us as an extension of your team—driving innovation while keeping risk in check.
