TPM Labs
TPM Labs is a specialized biocompatibility testing laboratory providing ISO 10993 testing services for medical devices. The laboratory offers comprehensive biological safety evaluation including cytotoxicity, sensitization, irritation, and systemic toxicity testing to support FDA and EU MDR regulatory submissions.
TPM Labs is a dedicated biocompatibility testing laboratory specializing in ISO 10993 biological safety evaluation for medical devices. The laboratory provides comprehensive testing services including cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-23), systemic toxicity (ISO 10993-11), and genotoxicity (ISO 10993-3) testing. TPM Labs supports medical device manufacturers with testing programs designed to meet FDA 510(k), PMA, EU MDR, and other global regulatory requirements. The laboratory maintains GLP compliance and works with clients to develop efficient testing strategies that minimize costs while ensuring regulatory compliance. TPM Labs focuses on providing high-quality, reliable testing services with fast turnaround times.
About
**Who they are**
TPM Labs is a technical program management firm focused on enhancing organizational efficiency and team collaboration. They specialize in providing leadership and strategic insights for complex programs.
**Expertise & scope**
* End-to-end technical program management
* Leadership and thoughtful insights for strategic programs
* Team coaching and development to drive efficiency, cohesion, and transparency
* Alignment of company vision, goals, and teams with strategic projects
* Comprehensive "State of the Union" reports with critical takeaways and recommendations
* Clarification and refinement of project scope
* Development of phased program plans
* Building team and stakeholder alignment
* Dependency management across teams
* Risk management and mitigation planning
* Development of metrics for data-driven decision making
* Alignment of initiatives with company goals, ensuring they are actionable and measurable
**Reputation / proof points**
* Addresses gaps and scaling challenges
TPM Labs is a technical program management firm focused on enhancing organizational efficiency and team collaboration. They specialize in providing leadership and strategic insights for complex programs.
**Expertise & scope**
* End-to-end technical program management
* Leadership and thoughtful insights for strategic programs
* Team coaching and development to drive efficiency, cohesion, and transparency
* Alignment of company vision, goals, and teams with strategic projects
* Comprehensive "State of the Union" reports with critical takeaways and recommendations
* Clarification and refinement of project scope
* Development of phased program plans
* Building team and stakeholder alignment
* Dependency management across teams
* Risk management and mitigation planning
* Development of metrics for data-driven decision making
* Alignment of initiatives with company goals, ensuring they are actionable and measurable
**Reputation / proof points**
* Addresses gaps and scaling challenges
Additional information
TPM Labs focuses on empowering teams to achieve their best work efficiently and seamlessly. They offer services designed to improve project execution through data analysis, leadership alignment, and team development. Their approach emphasizes transparency and cohesive collaboration to ensure organizational goals are met. They are available to discuss complex project needs and build partnerships.
Key Highlights
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Provides end-to-end technical program management for strategic and complex programs.
Source
“For your strategic and complex programs, we provide end to end technical program management, leadership, and thoughtful insights to your teams to ensure your organization’s desired outcomes.”
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Offers team coaching to drive improved efficiency, cohesion, and transparency.
Source
“We’ll coach your existing team to drive improved efficiency, cohesion, and transparency.”
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Develops metrics for data-driven decision making and alignment of initiatives with company goals.
Source
“Develop Metrics to allow for Data Driven Decision Making Alignment of initiatives with company goals (actionable & measurable)”
Certifications & Trust Signals
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Focuses on addressing gaps and scaling challenges within organizations.
Source
“Addresses: address gaps, scaling”
Buyer Snapshot
Best for
- Organizations seeking to improve project efficiency and team output
- Companies needing strategic program management and leadership
- Teams requiring coaching for enhanced cohesion and transparency
How engagement typically works
- Collaborative program management
- Data-driven insights and recommendations
- Team coaching and development
Typical deliverables
- "State of the Union" reports
- Phased program plans
- Risk mitigation plans
- Metrics for data-driven decision making
Good to know
- Best when organizations are looking to align strategic projects with company vision and goals.
HQ:
Portland, US
Languages:
English
Timezones:
America/Los_Angeles
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Industries:
Medical Devices
Pricing model:
Per project
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity
Is Accredited:
Yes
Glp Compliant:
Yes
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
3-5 business days
Rush Available:
Yes
Sample Return Policy:
Both options
Nda Support:
No
Minimum Project Size:
<$10k
Has In House Toxicology:
No
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Regions Served:
United States
