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Give your device a healthy start

Preclinical medical device development

Expertise and capacity to handle your preclinical testing needs—however simple or complex.

  • 40+ years of experience in preclinical medical device testing and consulting

  • Our 150 dedicated specialists conduct ~6,500 studies per year*

  • Specialized guidance to advance your device development so you gain clarity in complexity

What is preclinical medical device development?

Before any medical device can be used for patient care, it must go through rigorous preclinical testing. Preclinical medical device development is the first stage of development in the life cycle of a medical device or combination product, involving the use of specialized tests that mitigate the device’s potential for risk while maximizing its safety and regulatory compliance.

Image of a person getting their blood drawn. Medical professional is wearing gloves

YES.  You can test your medical device with a suite of nonclinical testing studies at Labcorp.

Need to test your medical device, combo product or drug-delivery system?  Know you have a trusted source for preclinical study services dedicated to medical device testing, including microbiology/reusability validation, biocompatibility, efficacy and surgical services, and analytical chemistry. Plus, near-term study availability means you can get your device testing started quickly.  Get a fast quote today.

Product development testing solutions

Biocompatibility

Proving that your device materials and manufacturing processes are biologically compatible is a regulatory requirement of every device. With Labcorp, that requirement just became easier and more streamlined. ​

  • Full scope of in vitro and in vivo ISO 10993 Biocompatibility studies performed in-house, including core Cytotoxicity, Sensitization, and Irritation

  • Cell-based in vitro alternatives available

  • A customized evaluation roadmap, plus study selection and protocol design

  • Regulatory support and guidance

  • Detailed data insights, reporting and much more

Deflated and inflated stents and balloon catheters, illustration.

Microbiology and reusability validation

Whether you seek to prove device sterility or secure reusability validation – we can help. Our microbiology testing portfolio covers:

  • Reusable device validations

  • Lot-release (bioburden, sterility, endotoxin)

  • Microbial ingress testing

  • Antimicrobial/preservative effectiveness testing

Uniquely positioned to provide quality and timely microbiology & reusability validation studies you can benefit from our 40+ years of experience in order to get the clarity and answers you need to move forward.

Shot of a young scientist working with medical samples in a lab

Analytical chemistry

Every device program needs analytical chemistry to evaluate the chemical makeup of the device and the materials that have direct or indirect bodily contact, in order to comply with regulatory standards.

We conduct all of our analytical chemistry studies with proprietary methods of screening for a variety of compounds, delivering the high level of quality science you expect using state-of-the-art instrumentation, such as ICP/MS, GC, GC/MS, HPLC and LC/MS.

We have deep experience with extractables and leachables, manufacturing residual testing, compendial analysis, dose verification and validation, chemical characterization, storage and stability testing along with an array of validation methods to serve diverse clients around the world. ​

Person wearing a medical mask for anesthesia

Efficacy and surgical services

Looking to confirm your device’s efficacy or elevate your bioskills and cadaver training? Labcorp’s surgical services is well poised to be a key part of your development program. ​ Our team includes dedicated surgical specialists who can perform a full range of studies and analysis, as well as physician/field team training which can also feature secure live-streaming capabilities for a more inclusive and broader virtual audience.

With two, state-of-the-art surgical facilities outfitted to support your preclinical surgical model development and efficacy testing programs – we can help in solidifying that your device works as designed, is safe for the patients who need it the most and that you have the proper training and knowledge to continue moving forward. 

Portrait of specialist nurse in operating theatre

Consulting and risk assessment

Knowing how to navigate a regulatory submission process across various global regulatory bodies can be challenging, especially when every decision is crucial to your device or combination product’s market approvals. ​

Our specialists will partner with you to develop a customized plan and make recommendations that guide you towards important milestones in an accelerated manner. 

We support you through preclinical medical device development and submission processes – so, you can be confident that the right tests, data and reports are delivered to meet regulatory compliance. 

Three scientists working in a laboratory. They are bending over a table looking at data and a paper.

Customize your solutions for your preclinical medical device testing

You need a lab partner who can provide the testing you need, quickly, efficiently and confidently and at Labcorp, you'll benefit from our deep knowledge in preclinical medical device testing to navigate its complexities as well as the regulatory requirements. Whether you need a single standalone study or a comprehensive testing portfolio, we partner with you to provide the precision, clarity and insights needed to advance your device or combination product to the next stage of development. We can deliver an entire toxicological risk profile of your device or combination product, streamlining your development which saves you crucial time and budget. 

No matter the therapeutic area your device is designed to address, our team of specialists can provide the strategic support you need. Our deep experience in preclinical medical device development spans several top indications, including:

  • Orthopedics

  • Cardiovascular

  • Diabetes

  • Drug Delivery

  • General Health (Wearables)

  • Neurology

  • Oncology

  • Ocular

  • Bariatrics

  • Wound Healing

By the Numbers

Count on our extensive experience to keep your device moving forward.

40+ years of expertise in the medical device space
~6,500 preclinical medical device studies conducted per year*
90+ state-of-the-art study rooms
10+ years average experience per scientific staff member
2 bi-coastal Centers of Excellence in the Bay area of California and Boston/Cambridge region of New England

* 5 year data from 2017– 2021 (including Q1 2022)
** Count of nonclinical device-dedicated staff and study rooms as of Jan 2023

Featured Content

Biocompatability explained - A primer and refresher

Labcorp's coffee talk presentation and MD&M West 2023

Leverage our team to expand the capabilities of yours

We listen first and develop strategies second. Working as an extension of your team, we bring decades of experience and deep insights to your program. Our medical device specialists are key leaders within organizations that shape the science, regulatory and ethical areas of preclinical medical device development. Several of our team members are vice presidents, chair members or serve integral roles in leading organizations and committees including organizations like:

  • ISO 10993 Biological Evaluation

  • Association for the Advancement of Medical Instrumentation (AAMI)

  • Society of Quality Assurance (Medical Device Specialty and GLP)

  • Society of Quality Assurance (Medical Device Specialty and GLP)

  • American Society of Microbiology

  • American Association of Clinical Chemistry

  • Association of Research in Vision & Ophthalmology

  • American Chemical Society 

452414323
USA, Oregon, Portland

Consolidating your testing programs has never been easier. 

No two medical devices are the same. Recognizing the unique characteristics of each device, we design highly customized plans to meet your product’s specific requirements and regulatory submission criteria.

With our full complement of preclinical medical device development, you gain access to a wide range of study designs to deliver the answers you need as quickly and efficiently as possible. From biocompatibility, microbiology, analytical chemistry and surgical services, we’ll help you thoroughly assess the safety & efficacy of your device and the materials it is made of to gain the confidence you need to advance your development program forward. 

Quality is our priority

Your studies are conducted in multi-certified laboratories following the highest possible non-GLP, GLP and GMP standards, including:

  • United States Pharmacopeia

  • Japanese Pharmacopeia

  • European Pharmacopeia

  • British Pharmacopeia

  • Chinese Pharmacopeia

  • ISO 10993 – Medical Device Evaluation

  • ISO 11979 – Ophthalmic Implants - Intraocular Lenses 

  • ISO 7405 – Dentistry

  • ISO 18562 - Breathing Gas Pathways

  • AAMI ST98 - Cleaning validation of healthcare products

  • ASTM

  • MHLW

Improving patient lives is at the center of everything we do. We know that your medical device or combination product has the potential to bring greater outcomes to patients in need. That’s why we share your mission to advance your medical devices and combination products with a sense of urgency. From developing clear roadmaps to communicating proactively and streamlining workflows, we work with speed and efficiency at every turn to keep pace with your important milestones.  

 

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Together, we can give your device a healthy start.
Let’s start the conversation.