He is an executive with solid experience in sales of studies and pre-clinical and scientific laboratory tests, acquired during more than 20 years of relationship with the medical device industries in Brazil, Latin America, and European countries.
A special highlight for his strong knowledge of the laboratory's quality system, such as GLP – Good Laboratory Practices (OECD and 21 CFR Part 58), ISO/IEC 17025 and test methods such as ISO 11737, ISO 10993, USP, EP, BP, ASTM, AAMI and FDA guidelines.
Max Bernardes is also a specialist in training and sales of biocompatibility studies (ISO 10993), packaging and product stability studies (ISO 11607 and ASTM F1980 – accelerated and in real-time), certification and monitoring of cleanrooms (ISO 14644), sterilization and monitoring validation (ISOs 11137, 11134 and 17665), validation of purified water systems (WHO and USP).
The executive is a speaker at symposia and workshops or the client's company, aimed at training technical and production professionals to improve contamination control in the manufacturing process and is a member of the study and internalization committee of ISO standards at ABNT/CB-026/CE 026 130 001 “Biological and Clinical Evaluation of Health Products”.