Our Services
Product Development
Product Development (Hardware & Software)
PTL ensures product development and regulatory requirements progress in parallel.
We support:
- Mechanical hardware
- Electrical hardware
- Software development (including SaMD and embedded systems)
- Wearables and soft goods
- Cybersecurity, human factors, and interoperability considerations
Project / Program Management
We act as the central coordination point to keep programs on schedule and within budget.
- Our role includes:
- Timeline and milestone management
- Cross-functional leadership
- Risk-based program oversight
- Design transfer readiness
Design Controls & Documentation
PTL takes a very strategic approach to help companies prepare their documentation for regulatory review. It starts well before the implementation of any QMS procedures, and really starts with the development of draft documents to ensure the project is moving in the right direction, and minimizes effort when formal procedures are implemented. We provide comprehensive support for design control execution and ensure regulatory submissions have all the essential evidence documented in a compliant manner:
- User needs, intended use, requirements
- Verification and validation planning and execution
- Biocompatibility, sterility, electrical safety
- Traceability matrices
- Risk management and DHF/DMR creation
Product Experience
PTL Solutions has supported a wide range of medical technologies. Our experience includes: