TPL Consulting

TPL Consulting is a full-service medical device consulting company that specializes in concept to commercial project management.

Services

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

About Us

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!