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 provides technical program management, leadership, and insights to help organizations achieve their desired outcomes for strategic and complex programs. They focus on aligning talent pipelines with business needs through a demand-driven approach.

**Expertise & scope**
* End-to-end technical program management
* Leadership and thoughtful insights for teams
* Workforce development training on the Talent Pipeline Management (TPM) approach
* Facilitating partnerships between employers and education providers
* Coaching existing teams to drive improved efficiency, cohesion, and transparency
* Crafting plans to map company vision, goals, and teams to strategic projects
* Clarifying and refining scope
* Developing phased program plans
* Building team and stakeholder alignment
* Managing dependencies across teams
* Risk management and mitigation planning
* Developing metrics for data-driven decision making
* Aligning initiatives with company goals in an actionable and measurable way

**Reputation / proof points**
* Offers a comprehensive "State of the Union" report with critical takeaways and recommendations.

Additional information

TPM Labs emphasizes a demand-driven strategy to align talent pipelines with business needs, facilitating partnerships between employers and educational institutions. Their services are designed to boost project efficiency and amplify team output through clear planning, stakeholder alignment, and data-driven decision-making. They offer coaching to enhance team cohesion and transparency, ensuring that company vision and goals are directly linked to strategic projects. Engagement typically involves collaborative evaluation of team dynamics and project execution to address gaps and support scaling initiatives.

Key Highlights

  • 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.”
  • Offers workforce development training on the Talent Pipeline Management (TPM) approach. Source
    “TPM Academy offers workforce development training on the Talent Pipeline Management (TPM) approach, a demand-driven strategy to align talent pipelines with business needs.”
  • Facilitates partnerships between employers and education providers. Source
    “They facilitate partnerships between employers and education providers.”
  • Coaches existing teams to drive improved efficiency, cohesion, and transparency. Source
    “We’ll coach your existing team to drive improved efficiency, cohesion, and transparency.”
  • Develops metrics to allow for data-driven decision making. Source
    “Develop Metrics to allow for Data Driven Decision Making”

Buyer Snapshot

Best for
  • Organizations seeking to improve project efficiency and team output
  • Companies needing to align strategic programs with company goals
  • Businesses looking to develop talent pipelines and foster employer-education partnerships
How engagement typically works
  • Collaborative evaluation of teams and projects
  • Coaching for existing teams
  • Strategic planning and alignment
Typical deliverables
  • End-to-end technical program management
  • "State of the Union" report with recommendations
  • Phased program plans
  • Metrics for data-driven decision making
  • Alignment plans for company goals
Good to know
  • Best when addressing complex strategic programs requiring improved efficiency and team alignment.
HQ: Portland, US
Languages: English
Timezones: America/Los_Angeles
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
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