Design Controls & Design History File Support Vendors
Implementation and documentation of medical-device design controls, including user needs, inputs, outputs, reviews, verification, validation, traceability, and design history files.
Related workflows
CDMO / CMO · +3 more types
StarFish Medical is a medical device CDMO providing device design, regulatory affairs, contract manufacturing, and cleanroom assembly services.
Products: ELLA, Pathfinder
Evidence-backed capability match
“Our team works closely with development and quality leaders to strengthen design controls, risk management, and documentation — reducing late-stage surprises and protecting…”Source: starfishmedical.com
Also offers: Medical Device Product Design & Engineering, Prototyping & Design for Manufacturing, +2 more
CDMO / CMO · +5 more types
DCN Dx is an IVD CDMO and CRO providing assay development, clinical trial operations, regulatory support, and manufacturing services.
Products: miniDxR, MICA-200C +1 more
Evidence-backed capability match
“Every customized miniDxR unit comes with standard features: pre-submission materials, product and software requirements, risk analysis, cybersecurity measures, verifications, and…”Source: dcndx.com
Also offers: IVD Assay Development, IVD Manufacturing & Scale-Up, +2 more
Consulting / Advisory Firm · +2 more types
Rook Quality Systems provides consulting and research services for medical device quality systems, regulatory strategy, clinical studies, and validation.
Evidence-backed capability match
“As a medical device quality systems consultant, we can assist your team with the creation and maintenance of Design History Files (DHF) and Technical Files (TF), ensuring…”Source: rookqs.com
Also offers: Quality Management System (QMS) Consulting, Medical Device & IVD Regulatory Affairs, +1 more
Compare listed vendors
| Vendor | Delivery model | Also offers | In their words |
|---|---|---|---|
| DCN Dx | CDMO / CMO | Prototyping & Design for Manufacturing | “Every customized miniDxR unit comes with standard features: pre-submission materials, product and software requirements, risk analysis, cybersecurity measures…”dcndx.com · reviewed Oct 14, 2026 |
| Rook Quality Systems | Consulting / Advisory Firm | — | “As a medical device quality systems consultant, we can assist your team with the creation and maintenance of Design History Files (DHF) and Technical Files…”rookqs.com · reviewed Oct 14, 2026 |
| StarFish Medical | CDMO / CMO | Medical Device Product Design & Engineering, Prototyping & Design for Manufacturing, Combination Product Development & Engineering | “Building that controlled manufacturing record can require: manufacturing documentation device history and traceability design-control and DHF support”starfishmedical.com · reviewed Oct 21, 2026 |