Science microscope lens, scientist hands and laboratory research, medical innovation and biology test. Closeup glass slide, chemistry investigation and pharma expert with dna virus bacteria analysis


Risk Assessment and Consulting Designed to Accelerate Your Device or Combination Product’s Development

Labcorp’s consulting and risk assessment services guide you and your device to key milestones

Discover best practices and avoid common pitfalls while working toward development milestones

Deep knowledge of differing global regulatory requirements for preclinical testing

Our consultants partner with you to get the required testing completed and you’re guided through the submission process

Realize the benefits of consulting and risk assessment

Unsure of the best strategy to move your medical device or combination product forward? That’s where Labcorp comes in. With more than 40 years of experience, our consultants will help you determine the best plan of action and mitigate risk throughout the entire preclinical testing process, saving you time in your development journey and maximizing the likelihood of regulatory approval.

A female doctor holds out an inhaler as she instructs her young patient on how to properly use it for her Asthma. The patient is dressed casually and sitting up on the table as she pays close attention to the instructions.

Preclinical consulting and risk assessment services

Our specialists have deep knowledge of the various global regulatory requirements for preclinical testing, acting as insightful advisors for keeping your device program on track toward the compliance and market approvals you seek.

Our consulting services portfolio includes:

  • Chemical characterization (toxicological risk assessment) - ISO 10993-17
  • Biological safety and validation ISO 10993-1
  • ISO 14971
  • U.S. Food and Drug Administration biocompatibility guidance
  • Global regulatory strategy and compliance
  • Study design/animal modeling
  • Physician/field team training and consulting
  • Pre-submission strategy
  • Risk management of material change
  • Gap assessment of historical biocompatibility data
Mature man at medical examination or checkup in otolaryngologist's office. Doctor Fitting To Male Patient Hearing Aid.

Obtain immediate access to premium consulting and guidance

Knowing how to navigate a regulatory submission process across various global regulatory bodies can be challenging and stressful, especially when every decision is crucial to your device or combination product’s market approvals. Our consultants will partner with you to develop a proactive plan, conduct risk assessments and make recommendations to apply best practices and avoid common pitfalls while guiding you toward reaching your development milestones.

Mature businessman discussing project with colleague during meeting in office


By the Numbers


preclinical medical device studies conducted per year


highly experienced preclinical medical device specialists


average years of experience per specialist

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 urgency to advance your medical devices and combination products. Whatever your goals and milestones, we’ll help you reach them on time. From developing clear road maps to communicating proactively, we work with speed and efficiency at every turn to keep pace with your important milestones

You may also be interested in:

 Male medical professional using computer in laboratory. Doctor is working in hospital during coronavirus outbreak. He is wearing protective face mask and uniform.

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

Contact Us