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“We support Medical Device companies in all stages of the product lifecycle, by offering a wide range of services including quality management system implementation, regulatory strategies, product development and verification, design transfer (for production), and risk management.
Aligned with our customers' business strategy we help them introduce their medical device to the market, guiding them in the process from the idea to release for production.
Our approach is process-oriented, pragmatic and diligent, aiming to always provide a lean solution, without compromising on compliance and conformance.”
- Ventzeslav Iordanov, Lead Consultant