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

Our full-service medical device testing lab can provide you with answers to even the most complex product analysis and development questions regarding medical devices, pharmaceuticals, polymers & plastics, and food & beverages.  Call us today at 800-930-5450.

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

Should you encounter a problem with your product or are looking to make a change or improvement that may take months or years to build, consider Avomeen’s product analysis. We’re skilled at testing and planning medical devices, and can provide your business with additional services as needed.

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

From discovering fundamental technology breakthroughs, to matching technology to market needs, to product extension and adjacency expansions, let the experts at Avomeen’s medical device testing laboratory ensure the success of your project.

For more information, contact us or call 800-930-5450.