CDMO / CMO · +3 more types
Products: ELLA, Pathfinder
“StarFish provides medical device manufacturing services that establish the processes, suppliers, documentation, quality controls, testing and production planning required for…”Source: starfishmedical.com
Also offers: Medical Device Product Design & Engineering, Prototyping & Design for Manufacturing, +1 more
CDMO / CMO · +5 more types
Products: miniDxR, MICA-200C +1 more
“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
“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
CRO / Research Services Provider · +5 more types
“Extractable/Leachable (E/L) study for drug product container/closure”Source: frontagelab.com
Also offers: Bioanalysis & Biomarker Assay Services, Integrated CDMO/CMO Services, +3 more
CRO / Research Services Provider · +3 more types
Products: Acceleration Platform
“Terminal sterilization services from Altasciences deliver sterility assurance for parenterals, ophthalmics, and other pharmaceuticals under cGMP standards.”Source: altasciences.com
Also offers: Toxicology Studies, First-in-Human (Phase I) Clinical Pharmacology Support, +2 more
CRO / Research Services Provider · +5 more types
Products: Teklad, Target Sufficiency +1 more
“Our team of board-certified medical device pathologists utilizes advanced techniques and methodologies to evaluate the biocompatibility, safety, and/or efficacy of medical devices…”Source: inotiv.com
Also offers: Toxicology Studies, In Vivo Pharmacology & Efficacy Models, +3 more
CRO / Research Services Provider · +7 more types
Products: IQVIA Vigilance Platform, SmartSolve +4 more
“Assess baseline safety, usability, and user interaction to support early device validation.”Source: iqvia.com
Also offers: Full-Service Clinical Trial Execution (CRO Services), Real-World Data Platform, +6 more