Preclinical consulting services including:
- regulatory quidance
- pre-clinical development plans
- project management
- toxicology consulting
- toxicologal testing plans
The areas of consultancy
- toxicology testing
- efficacy testing
- safety testing
- PK testing
AaMEDI provides following services:
- Medical Device (preclinical, biocompatibility, regolatory, R&D)
- Experimental Animals (keeping, breeding, using, all kinds treatment methodes)
- In vitro methodes as alternative to animal experiments
- International intercultural relationships (Asia and Northamerika)
AaMEDI's staff has experience more than 20 years in the field of biocompatibility of medical devices, biomaterials and pharmaceutical and cosmetic products. Experience in the areas of in vivo and in vitro test systems, toxicology and histology can be resorted to. We can also offer advice in the field of planning, construction, commissioning and management of various laboratories in the field of in vivo and in vitro.
AaMEDI can offer support with the development of medical devices up to the final product, the assessment of the biocompatibility of medical devices, the preparation of declarations of conformity, representation of the manufacturers and developers at the respective authorities worldwide, consulting of the development teams within the companies and with the respective processes in development and production.
OUR CUSTOMERS are from all ranges, eg that directly or indirectly manufacture, buy, sell, market and/or trade medical devices.
Every medical product is different. The requirements for the development, production and marketing of medical devices are enormously complex, time- and resource-consuming. Countless, constantly changing legal requirements worldwide must be observed. This requires years of experience and profound knowledge.