Strategic Partner

TPL Consulting

TPL Consulting is a full-service medical device consulting company that specializes in concept to commercial project management. Coming from medical device manufacturing with a foundation in biomedical science, TPL can assist in any scale of project. Whether in concept and feasibility or fully marketed and maintaining compliance, we can offer the highest quality outputs while preserving the allocated budget. While we love getting in on the early phase development and building out a Quality Management System as the design progresses and ultimately submitting for market approval, auditing for MDSAP, MDR, ISO 13485 and QMSR are foundation services that we provide.

Are you struggling with sterilization and biocompatibility requirements or failures? This is a specialty for us!

Compliance Services: FDA 820 | ISO 9001 | ISO 13485

• Design Assurance 
• Regulatory Strategy and Submission 
• Auditing 
• Risk Management 
• Total Product Life Cycle 
• Mock FDA Inspections 
• 483 Remediation 
• Q-Submissions and IDE Submissions