Preclinical testing for medical devices is a complex process of evolving device design and regulatory-driven requirements. Our goal is to support the determination of the success of your device design, and to build a solid foundation that spans all stages of development from pre-clinical GLP and non-GLP studies at the feasibility/prototype stages to safety and efficacy studies. ISIS preclinical testing services encompass the range of potential testing requirements by regulatory agencies such as:
- General acute and repeat dose toxicology studies
- Local irritation and hypersensitivity studies
For combination products (device and drug), ISIS also offers comprehensive preclinical testing for the device component and the drug component, including standard pharmaceutical analysis and biosafety testing required to support your IND.
- Toxicokinetic/Pharmacokinetic studies
- Single dose toxicity studies
- Repeated dose toxicity studies
- Local tolerance studies
- Carcinogenicity studies
- Neurotoxicity studies
- Acute toxicity studies
- Animal efficacy models
ISIS’ experience in these studies spans the range of indications, including: cardiovascular, orthopedic, gastrointestinal, urogenital, dermatological, wound healing, model development, neurology, oncology and inhalation studies. Our experience provides you expert guidance in the preparation of your protocols and the conduct of studies, allowing you to develop the requisite data package and reports for PMA, 510K, IDE, BLA and IND submissions.