Medical Device Engineering
Medical device work carries documentation obligations that general mechanical work does not. A drawing package has to survive audit as well as reach a supplier, and design decisions have to be traceable back through the design history file.
We provide mechanical design and documentation capacity to medical device manufacturers and their contract engineering teams, structured so it drops into an existing quality system without rework.
Scope of Work
| Area | Detail |
|---|---|
| Design documentation | Drawing packages, specifications and design records prepared to fit an existing design control process. |
| DHF documentation support | Design History File structure, risk management file inputs (ISO 14971), design controls. |
| Design for regulated manufacture | Design for manufacture in cleanroom and controlled environments. Biocompatible material selection to ISO 10993. |
| Design freeze packages | Complete drawing sets, bills of material and specifications prepared to support a 510(k) or PMA submission. |
| ISO 13485-aware process | Deliverables structured to sit inside an existing quality management system, not retrofitted before submission. |
| Prototype design | Concept through functional prototype, structured for design iteration and eventual freeze. |
A Note on Scope
Stellar Forged provides mechanical engineering and design documentation. We are not a regulatory consultancy and we do not act as your submission agent. We produce the engineering record a submission is built on, and we work alongside whoever holds your regulatory strategy.