Medical Device Testing Laboratory

medical-device-testing-laboratoryAvomeen is a medical device testing laboratory that develops innovative solutions in order to solve analytical, safety, and regulatory questions.  Our medical device testing services help you solve non-routine, unusual, and highly complex problems.  Avomeen is FDA, GLP, and cGMP compliant, DEA-Licensed (class I-V), and ISO 17025-Accredited.

Our full-service lab can support you through the entire medical device product development cycle. We can also assist with post-market medical devices. Come to us for help with surgical, diabetes-related, cardiovascular, urological, neuromodulation, spinal, and countless other medical device categories. An analysis by our highly-trained and experienced scientists includes deep examination of standard medical devices as well as drug-device combination products.

Medical Device Testing Laboratory Services Include:

  • Materials Analysis
    • Deformulation – Chemical Characterization, Identification, Quantification
      • Component Identification
      • Competitor Product Analysis
    • Raw Material Analysis
    • Additive Analysis
    • Commercial Fatigue & Durability
    • Microbial Identification
  • Stability Testing
    • Degradation & Deteriorating
      • Biodegradation
      • UV
  • Extractables & Leachables Testing
    • Product Immersion
    • Product Flush
    • Bioanalysis
  • Method Development & Validation
  • Formulation & Process Development
    • Client retains all IP rights
  • Quality Control
    • Cleaning Studies
  • Pharmaceutical R&D, Packaging Analysis, & Polymer Testing
    • Raw Materials, Resins, & Additives Composition Identification
  • Failure Analysis
    • Contamination Identification
    • Defect Analysis
  • Consulting Services
    • Regulatory & Compliance Support
    • Certification & Auditing
    • RoHS
  • Litigation Support
    • Expert Witnesses
    • Intellectual Property Issues
    • Product Failure Investigations

From Product Conceptualization to Post-Market Production

  • Competitor Product Analysis – Gain an edge in an increasingly competitive market. Our deformulation services help you to reverse engineer and modify existing formulations & technologies to help your company keep up with the changing technology within the medical device marketplace
  • Technology Innovations – Stay on the cutting edge with next-gen technology innovations from our medical device formulation and process development team
  • Faster Time to Market & Reduced Cost – We will streamline your medical devices development process implementing resulting in faster time to production and reduced cost.
  • Drug Device Combination -Navigate the R&D process to create successful drug device combination products
  • Rapid Regulatory Approvals – Navigate the regulatory environment and overcome tightening global regulations through our regulatory consulting services
  • Full-Service Laboratory – Acquire both routine and non-routine analytical support giving you a higher level of R&D resources
  • Product Failure Reduction – Obtain raw material verification, process development, and manufacturing support

Our Scientists have experience with:

  • Coronary Stents
    • Drug-Eluting Coronary Stents
    • Drug-Coated Stents
  • Antimicrobial Catheters
    • Polyurethane Catheter
  • Photodynamic Therapies
  • Orthopedic Applications
    • Bone Cement Including Antibiotic
    • Bone Graft Substitutes
    • Orthopedic Prostheses
  • Dental Materials
  • Ophthalmic
    • Contacts
    • Glasses
  • Cardio
  • Wound Care
    • Including Those for Biological Dressings
    • Sutures
  • Drug Delivery & Drug-Combination Products
    • Nanotech Combination Products
    • Drug-Eluting Beads
    • Ocular Applications
  • Implantables
  • Antimicrobials & other Medical Device Coatings
  • Novel Class Products
  • Membranes & Filters
  • Flexible Tubing, Containers, Packaging, & Protective Products
  • Coatings
  • & Other Medical Devices

If you have a complex analytical problem that needs solving, please:

Use our quick quote form or contact us for more information.