Frequently Asked Questions
Every project is unique, and so are the questions that come with it.
Below you’ll find answers to the most frequently asked questions about our engineering solutions, manufacturing capabilities, project workflow, and confidentiality practices. We believe in clear communication, technical excellence, and protecting our clients’ information at every stage of the process.
Need more details? Our team is always available to discuss your specific requirements.
What does ASDE actually do?
We design, build, and validate complete production systems for regulated products —
from concept to the factory floor.
Can you start from just an idea?
Yes. We regularly begin with a concept or an early prototype and deliver a validated
production line.
What industries do you work in?
Medical devices (Class I–III), biotech, and other highly regulated industries.
Can you work under our quality and regulatory requirements?
Yes — ISO 13485, FDA 21 CFR 820, and ISO 14971
risk management.
Do you build the equipment, or only design it?
Both. We design and build the automation, custom equipment, and production lines, then qualify them.
How do you handle confidentiality? We don’t disclose client names or project details. Every engagement is covered by
confidentiality agreements