SESBO Consulting helps companies around the world to develop and adapt medical equipment according to the requirements of regulatory agencies such as FDA, ANVISA and CE. We conduct a dialogue between certification bodies, testing laboratories and regulatory agencies.

Foundress

Sara Oliveira is a senior consultant who aims to provide follow-up, guidance and guidance so that all requirements, standards and tests necessary for the successful submission of medical devices to regulatory agencies (FDA, Anvisa and CE) are achieved.

With over 15 years of experience in the medical field, the following relevant areas stand out:

• Experience in development and regulatory requirements (such as FDA, ANVISA and CE) for medical products, almost 10 years of work in engineering in the medical industry.

• Monitor, supervise, define laboratory test measures for medical devices

• Lead teams of engineers and scientists in medical products and projects

• Represented Brazil by setting standards for medical ventilators at national and international level

• Strong technical knowledge, lectures on biomedical equipment at the University

• Leadership of 15 engineers for the development of medical devices and regulatory requirements

• Postgraduate Master in Electrical Engineering with emphasis on Microelectronics.

Regulatory motto: To play well, you need to know the rules of the game, this saves time and resources.