Services

Medical Device Testing

FDA

For a successful FDA clearance, it helps to have a well-characterized understanding of your mode of action and a testing strategy that is scientifically sound, statistically robust, and easily understood by the agency.

cell grids

Multilayered technologies often require different types of testing to meet regulatory requirements.

chemistry

iFyber is proud to provide a number of medical device testing services, integrated within your R&D team to provide the most appropriate testing.

To learn more about iFyber's unique approach read our recent blog: Medical Device Testing: Strategies for the Best Regimen

iFyber's Medical Device Testing Services

Biofilm and Antimicrobial Efficacy Testing:

iFyber provides a suite of antimicrobial susceptibility tests to verify the efficacy of antimicrobial medical devices.

Including: antimicrobial dressings, bio-engineered tissue products, biomaterials, bioactive dressings, and novel anti-infectives.

Biofilms form on a range of surfaces, including medical devices. iFyber has a suite of biofilm models to evaluate biofilm prevention and eradication on both abiotic and biotic surfaces.

Examples of relevant materials for biofilm testing include new antibiotics/biocides, coatings, nanomaterials, wound dressings, gels and ointments, wound washes, coated natural tissue matrices, and coated medical devices.

Biofilm and Antimicrobial Efficacy Testing

Cell-Based Assays:

iFyber has expertise in evaluating the effects of medical devices on mammalian biological systems. We implement high throughput, repeatable, relevant, and quantitative in vitro assays that provide clients with robust data from which to plan future product development and verification efforts.

We offer 2D and 3D models of tissue to evaluate cytotoxicity. We can also evaluate cytokines and growth factors to understand how a device or therapy impacts the healing process.

Cell-Based Assays

Sterilization Validation Services:

We work with our subsidiary, NovaSterilis, a provider of sterilization equipment and services, to provide R&D services.

During the sterilization validation process, our multidisciplinary team will help guide you in process and cycle optimization, material compatibility studies, measurement of sterilant residuals, and development of microbiological recovery and enumeration methods for validating scCO2 terminal sterilization of your medical device or biological product.

Sterilization Validation Services

Materials Testing:

iFyber can design and perform product-specific functional materials testing, such as evaluating mechanical properties, resorption rate, therapeutic ion release, antimicrobial activity, and biocompatibility.

Deformulation: Sometimes called reverse engineering, iFyber’s materials testing and analytical services program allow us to identify methods of action in medical devices to gain competitive intelligence or decide how to position a unique product with respect to its competition.

Materials Testing

510(k) Data Packages & Support:

Consulting:

To legally market a medical device in the US, manufacturers must design, develop, test, and manufacture products according to Current Good Manufacturing Practices (cGMPs) and other applicable standards and guidances. In support of these efforts, iFyber offers individualized regulatory and quality consulting services, including strategy development, regulatory submission support, and Quality Management System development.

Quality & Regulatory Consulting