Medical Device Evaluation Services

Leading Medical Device Developers Partner with StageBio—and Achieve Translational Research Success

With 20+ years of pathology expertise and regulatory insight, we can help you reduce risk and accelerate time to market for your medical device. 

We have conducted more than 1,000 Non-GLP and GLP medical device histopathology studies across multiple therapeutic areas, and we can tailor our highly efficient approach to serve your agenda, meet your study objectives, and adhere to your timeline.

StageBio Service Icons_Cardiovascular
StageBio Service Icons_Nervous System
StageBio Service Icons_Musculoskeletal

~70 per year

Cardiovascular Device Studies

 

~70 per year

Nervous System Device Studies

 

~20 per year

Musculoskeletal & Dental Device Studies

 

Trusted Experts in Medical Device Pathology

5
Medical device pathologists

with an average of 28+ years of experience

20+
Pathologists

Across all service lines with an average of 17+ years of experience

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.

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 histopathologic and morphometric evaluations of devices and biomaterials 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:

  • Immunohistochemistry
  • Plastic embedding
  • Optimized histology for unique components
  • Digital radiography
  • MicroCT
  • Image analysis
  • Necropsy support or oversight
  • Digital Microscopy
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

We are a quality-focused scientific team committed to open collaboration. StageBio offers a personalized approach with clear, insight interpretation to assist you with:

  • Study design
  • Protocol review
  • Scientific advisory support
  • Peer review
  • Problem solving
  • Due diligence

How to get started with our medical device evaluation services

Step #1

Connect with us for an initial discussion or request for proposal.

Step #2

Receive expert advice on your scope of work from our principal investigator, a pathologist, and other specialists.

Step #3

Collaborate with our team to develop the histopathology strategy specific to your objectives.

Step #4

Receive our StageBio estimate, undergo scheduling and launch the project.

Book a Call with Our Team!

Discuss your study goals and timeline with a StageBio expert to see how we can support your medical device evaluation study.


REQUEST A CONSULTATION

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

What sets us apart from our competition is our ability to work in partnership with our clients, providing study design assistance, specialized laboratory processes, bespoke morphometric evaluations, and high-quality pathology reports. Our clients rely on us for quality, precision, and GLP compliance to move their programs forward.”

Dr. Stephanie Shrader
StageBio, VP of Pathology Solutions

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