Medical Device Biocompatibility

///Medical Device Biocompatibility
Medical Device Biocompatibility2018-01-12T20:04:15+00:00

VxP Pharma supports our clients with medical device services from the initial “proof of concept” to biocompatibility and safety evaluations.  We offer an integrated approach to medical device studies by providing surgical facilities for major surgery and accommodation for small and large animals with clinical pathology assays able to be performed in-house for rapid analytical results.  We are committed to scientific excellence, appreciate client-specific issues, and understand the regulatory considerations with medical device development.

Our qualified technicians and pathologists can prepare and evaluate essentially all categories of medical devices including external devices, external communicating devices, and internal devices.  With our expertise in anatomical and clinical pathology and the state-of-the-art laboratories, VxP Pharma can provide complete service and support to device manufacturers and GLP/Non-GLP projects.

Services

  • Protocol preparation
  • Necropsy support
  • Sample preparation
  • Histopathology
  • Electron microscopy
  • Photographic documentation
  • Morphometric evaluation
  • Plastic embedding and sectioning of all materials (e.g., intact stents, bone devices)
  • Numerous imaging techniques

Experimental Surgeries

  • Acute or survival procedures
  • Cardiovascular models
  • Animal model development
  • Thoracic, abdominal, vascular or orthopedic surgery models
  • Dermal hypersensitivity and dermal absorption/PK testing
  • Metabolism studies
  • Infusion models
  • Atherosclerosis models
  • Biomaterial and chemotherapy implants
  • Small-animal cerebrovascular models

By partnering with VxP Pharma, you will have access to  a vast array of medical equipment and facilities for the most complex studies, as well as routine studies.

Top diagnostic imaging including:

  • Radiography
  • Ultrasound and color flow Doppler imaging
  • Fluoroscopy
  • CT scanning
  • MRI
  • Dual energy x-ray absorptiometry (DEXA)
  • Heart/lung bypass machine
  • Intra-operative radiation therapy

At VxP Pharma, we understand your needs and have the extensive experience working with the FDA, USDA, and EPA required to make your research projects a success.  Specifically tailored, individual study designs enable our clients to meet their product development goals and facilitate world-wide regulatory approval.  Our individualized approach to each study allows us to revise and shift directions based on your changing needs.

The state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.

Contact us today for a free consultation with the scientific team and discover how VxP can be a valuable resource and partner for your organization.