Digital Health Manufacturing & Packaginglinor2020-08-12T10:15:27+00:00
Manufacturing & Packaging in the digital health field
tools and developments are considered regulatory as medical devices. Therefore, the process of developing and manufacturing such products begins with the characterization, product design, product design and development, experimentation and technology execution, validation and validation processes, while ensuring the quality and safety of the technology that will be widely used by medical and patient teams
Knowledge and understanding of regulatory requirements, risk assessment, software code writing that meets the requirements of the World Health Authorities are just some of the issues required for both ISO 13485 certification and submission of product registration to health authorities such as the FDA and CE, intending to reach a product development and manufacturing process High-quality digital product with minimum delays, which will support the entire product life cycle.
The medical industry also includes software-integrated products, cellular applications, monitoring and measurement equipment, algorithms that should be updated in terms of their database (or the one they are using) and therefore must “function as needed” and robustly throughout the product lifecycle and move Periodic health checks.