Preclinical Medical Device Development

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. ​

Benefit from: ​

• 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

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 as a leading CRO for 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.

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. ​

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. 

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. 

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, GLP and Rapid Response Sections)
• Genetic Toxicology Association
• American Society of Microbiology
• American Association of Clinical Chemistry
• Association of Research in Vision & Ophthalmology
• American Chemical Society 

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 PharmacopeiaJapanese 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