Medical Device Expertise from
Concept to Commercialization
TPL Consulting delivers lifecycle-based consulting services that help medical device
companies navigate development, compliance, and market approval with confidence.
Why choose TPL Consulting?
TPL Consulting provides end-to-end medical device consulting services, supporting companies across the entire product lifecycle—from early concept and feasibility through design and development, quality system implementation, and regulatory approval. With proven experience securing FDA, EU MDR, Health Canada, and TGA approvals, we help medical device manufacturers navigate complex regulatory pathways with confidence. Our expertise in design controls, risk management, ISO 13485-compliant quality systems, and regulatory submissions enables clients to reduce risk, accelerate development timelines, and successfully bring compliant medical devices to market.
Darci Diage is the Founder and CEO of TPL Consulting, providing expert guidance across the full medical device product lifecycle—from concept through commercialization. With over 20 years of experience leading complex laboratories and Quality organizations, Darci specializes in design control, risk management, feasibility testing, and quality system implementation. She has supported successful device approvals across the U.S., EU, Canada, and Australia, working on cardiovascular, spinal, combination, and software devices. Backed by degrees in Molecular Biology and Biomedical Laboratory Science, Darci brings a practical, results-driven approach to navigating evolving regulations and aligning suppliers, service providers, and manufacturers to bring safe, effective devices to market.
M.S. Biomedical Laboratory Science, Owner, TPL Consulting
Darci Diage
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From concept to commercialization, expert guidance across the total product lifecycle.
