Medical Device Evaluation Services

Accelerating Medical Device Development with Trusted Pathology Expertise

 Implant to Insight: Fast, Compliant, Precise

With 20+ years of pathology expertise and regulatory insight, we help you navigate the pitfalls that often derail medical device development: incomplete planning, inadequate sample collection or processing, need for advanced techniques and specialized stains that compromises data quality, and the costly assumption that all suppliers offer equivalent pathology services.

We have conducted more than 1,000 Non-GLP and GLP medical device pathology studies across multiple therapeutic areas, delivering the specialized expertise and proactive guidance to move programs forward from day one.

Contact Our Experts

Why Work With StageBio

Choosing the right CRO means finding a partner who treats your project as their own priority. StageBio works as an extension of your team, combining consultative expertise with transparent collaboration to accelerate your path from study to submission. Our pathologists and scientists provide strategic insights beyond just data generation and reporting, helping guide the best approach from protocol design through regulatory filing. With decades of experience and a commitment to open dialogue and clear timelines, we deliver submission-ready data and reports aimed to contextualize the data advance your program with confidence.

 

StageBio Service Icons_Cardiovascular

~70 per year

Cardiovascular
Device Studies

 

StageBio Service Icons_Nervous System

~70 per year

Nervous System
Device Studies

StageBio Service Icons_Musculoskeletal

~20 per year

Musculoskeletal & Dental Device Studies

 

StageBio Service Icons_Wound Healing

~25 per year

Skin & Wound Healing 
Device Studies

 

Trusted Experts in Medical Device Pathology

5
Medical Device Pathologists

bringing breadth and depth, accelerating turnaround times and strengthening regulatory confidence

20+
Pathologists

delivering validated insights, regulatory-grade interpretation, and credibility you need to drive programs forward

Book a Call with Our Scientific Team

Connect with a StageBio expert to discuss your study goals, timelines, and how our pathology support can help you deliver the quality data for your project.


REQUEST A CONSULTATION

Our Medical Device Evaluation Services 

We offer a range of specialized GLP-compliant pathology services for medical devices to support your project from preclinical studies through regulatory submission. With our proven experience and deep expertise, we deliver the quality, timelines, and regulatory assurance you need, while providing strategic insights that add true value to your program.

Download our flyer for a full list of services we offer for medical device evaluation.

partners-in-research

Areas of Our Non-Clinical Evaluation Expertise

We conduct robust non-clinical evaluations (necropsy, histopathology, morphometry, image analysis) of devices and biomaterials in any tissue but specially in the following areas:

  • Cardiovascular
  • Musculoskeletal and dental
  • General medicine and surgery
  • Soft tissue implants
  • Nervous system
  • Wound healing
  • Ocular
  • Gastrointestinal
  • Dermal
  • Urinary system
  • Reproductive system

Study Development

We offer a wide platform including bespoke histopathology techniques, imaging, and analytics for:

  • Necropsy support or oversight
  • Optimized histology for unique components
  • Immunohistochemistry
  • Spurr and MMA embedding
  • Digital radiography
  • MicroCT
  • Digital Pathology
  • Morphometry & Image analysis
The evaluation of FG Putty and ATPase underneath a microscope displayed on computer screen
The evaluation of proximal cell underneath a microscope displayed on computer screen

Guidance

Our quality-driven scientific team is dedicated to open collaboration and flexible support. StageBio provides a tailored approach with clear, insightful interpretation to support you with:

  • Study design
  • Protocol review
  • Scientific advisory support
  • Problem solving
  • Peer review
Avoid Costly Delays and Reduce Your Project Risks 

Meet with our pathology team to discuss how StageBio's expert support can keep your study on track and deliver the quality data you need, when you need it.

Meet with Our Team

Resources

FLYER

Trusted Histopathology Support for Medical Device Development

VIEW

WEBINAR

Key Pathology Considerations for Successful Preclinical Medical Device Studies, from Protocol to Report

VIEW

PUBLICATIONS

Histopathological Evaluation of Orthopedic Medical Devices: An Overview of Tissue Collection and Sample Storage

VIEW

ARTICLE

Medical Device Pathology: The 7 Common Mistakes We Help You Avoid

VIEW

StageBio Service Pathway 07.25.25

Testimonials & Quotes

“I have worked with a number of pathologists now and I really appreciate the systematic approach to grading, the recognition that one event in one nerve bundle in one slide does not constitute a generalizable phenomenon.” Director of Pathology, Contract Research Organization
“There is literally no other group with this degree of knowledge, ability to put data in a context, and to be honest and direct with their client about the data. This really sets [StageBio] apart from other groups.” Study Director, Medical Device Organization
“At StageBio, what makes us stand out is the way we partner closely with our clients, supporting them with their study design input, specialized laboratory methods, bespoke morphometric evaluations, and comprehensive pathology reports. Our sponsors depend on us for precision, quality, and GLP compliance to ensure their programs move forward with confidence.” Jaime Paulin, DVM, MS, DACVP, StageBio, Senior Pathologist

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