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Preclinical Evaluation focuses on the determination of the non-clinical efficacy, safety and biocompatibility of wound management devices, catheters/stents, prostheses, and many other medical devices or combination products in order to evaluate potential risks of harm to the human body with regard to their intended use.
Preclinical consultation services by IASON consulting provide you with the maximum service throughout the development of your medical device or combination product.
Our team of best-educated, professional, and committed consultants gladly assists you not only from start to finish in the product approval process, but also in specific sections of research phases, as for instance, Preclinical Evaluations fully complying with international requirements and fulfilling ISO 10993-1.
Application procedures ½ Regulatory aspects ½ Conduct of studies ½ Required data ½ Literature reviews ½ Laboratory experience
IASON consulting can look back on a long and successful history of providing first class services within the health science industry including the provision of in vitro and in vivo preclinical evaluation projects for medical devices or compound products.
Every document by IASON consulting is subject to thorough investigation by qualified experts and is subject to high standard quality control before submitting to clients and subsequently official agencies.
IASON consulting expert knowledge includes
Pharmacodynamics ½ Pharmacokinetics ½ Acute toxicity ½ Repeated dose toxicity/carcinogenicity ½ Irritation/sensitisation ½ Safety pharmacology½ Local tolerance ½ Genotoxicity ½ Reproductive toxicity/teratogenicity
Contact us now for a Preclinical Evaluation tailored to your needs.