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Give your device a healthy start

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

What is microbiology in the medical device industry?

Microbiology testing of medical devices involves identifying the presence and risk of microbial contaminants. If not properly addressed, microbial contamination can cause serious threats to both personal and public health.

When you need to develop an effective microbiological testing strategy, count on our decades of experience. We’ll customize the right microbial assessments for your product that fulfill regulatory requirements. All of our studies are backed by a complete documentation package and are performed with a focus on quality with quick turnaround times.

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

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.

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By the numbers

~6,000 preclinical medical device studies conducted per year
150+ highly experienced preclinical medical device specialists
10+ 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

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