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 through data analysis and strategic alignment.
**Expertise & scope**
* End-to-end technical program management for strategic and complex programs.
* Leadership and insightful guidance for teams to achieve desired organizational outcomes.
* Coaching existing teams to improve efficiency, cohesion, and transparency.
* Developing clear plans that align company vision, goals, and teams with strategic projects.
* Clarifying and refining project scope.
* Creating phased program plans.
* Building team and stakeholder alignment.
* Managing dependencies across all teams.
* Implementing risk management and mitigation plans.
* Providing executive updates and bi-weekly program status reports.
* Developing metrics for data-driven decision-making.
* Ensuring alignment of initiatives with company goals, making them actionable and measurable.
**Reputation / proof points**
* Offers a comprehensive "State of the Union" report with critical takeaways and recommendations for better alignment.
TPM Labs is a technical program management firm focused on enhancing organizational efficiency and team collaboration through data analysis and strategic alignment.
**Expertise & scope**
* End-to-end technical program management for strategic and complex programs.
* Leadership and insightful guidance for teams to achieve desired organizational outcomes.
* Coaching existing teams to improve efficiency, cohesion, and transparency.
* Developing clear plans that align company vision, goals, and teams with strategic projects.
* Clarifying and refining project scope.
* Creating phased program plans.
* Building team and stakeholder alignment.
* Managing dependencies across all teams.
* Implementing risk management and mitigation plans.
* Providing executive updates and bi-weekly program status reports.
* Developing metrics for data-driven decision-making.
* Ensuring alignment of initiatives with company goals, making them actionable and measurable.
**Reputation / proof points**
* Offers a comprehensive "State of the Union" report with critical takeaways and recommendations for better alignment.
Additional information
TPM Labs focuses on empowering teams to achieve their best work efficiently and seamlessly. They specialize in providing strategic program management and leadership to ensure organizations meet their desired outcomes. Their approach involves deep expertise in coaching existing teams to drive improved efficiency, cohesion, and transparency. They craft clear plans that map company vision and goals to strategic projects, addressing gaps and scaling challenges. Buyers can expect a focus on data-driven decision-making and measurable alignment of initiatives with overarching company objectives.
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 comprehensive "State of the Union" reports for strategic alignment.
Source
“Leverage our comprehensive "State of the Union" report, highlighting critical takeaways and recommendations for better alignment.”
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Focuses on coaching existing teams to drive improved efficiency, cohesion, and transparency.
Source
“Create A+ talent with our deep expertise. 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
- Teams needing enhanced collaboration and transparency
- Companies managing complex strategic programs
How engagement typically works
- Collaborative coaching and development
- Data-driven analysis and reporting
- End-to-end program management
Typical deliverables
- Phased program plans
- 'State of the Union' reports
- Risk mitigation plans
- Alignment strategies
- Data-driven metrics
Good to know
- Best when seeking structured program management and team alignment
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
