2020-03-19
Realheart development plan 2020
Development Plan 2020
The three areas Realheart intends to work with during 2020 are: productization, supplier and partner collaborations for manufacturing, and FDA requirements specification.
productization
– Optimizing the mechanical properties of the pump
– Completing the design work to meet production requirements
– Initiating certification of the company according to ISO 13485 for medical technology companies
Supplier and partner collaborations for manufacturing
– Identifying suppliers and partners with experience in manufacturing high quality medical technology products
– Ensuring access to the most suitable suppliers for all critical components
FDA requirements specification
– Continued animal studies focusing on chronic animal trials and developing the surgery procedure
– Perform blood tests and flow studies using computerized programs and magnetic cameras
– Continuing the durability tests
“I am very proud of the work done by the team in 2019. It has prepared Realheart well for 2020 and onwards. Although it´s a few years left until Realheart TAH reaches the market, our work is becoming more and more concrete. I feel that not least now when we are actively searching for production partners”, says CEO and founder Azad Najar.