Biocompatibility data for CE mark according to ISO 10993.
Made was responsible for the whole biocompatibility package which was needed for medical device class III in order to get CE mark. This project included formulating a biocompatibility plan and monitoring the safety studies and biocompatibility report in order to ensure the medical device's safety according to ISO 10993. This project time schedule was two years from the beginning (the first literature review) until the Notifying Body accepted the biocompatibility data.
The project included the following steps:
- Identify the needed biocompatibility tests according to ISO 10993
- As determined in ISO 10993:1 (2018)
- Endpoints to be addressed in a biological risk assessment
- Literature review in order to find out the possible existing safety data (toxicological statement)
- Biocomapatibility plan
- Required biocompatibility/safety tests (offer round)
- Managing CROs
- In order to ensure the quality and timely delivery of required information
- Testing item and delivery of required information to the test laboratories
- Biocompatibility report
Tailor made in vivo services
The research organization had a new functional food compound. MADE was responsible for producing non-clinical safety and efficacy data in order to gain a marketing license with health claim according to EFSA guidelines. The safety studies that were required were mutagenicity, genotoxicity and 90 day toxicity study. The efficacy of the compound was proved using a hypertensive rat animal model. The necessary safety studies underwent the MADE CRO management process and MADE also performed an efficacy study. The project time was one year.