Medical Device Development, Testing & Manufacturing Vendors

Vendors supporting medical-device and combination-product design, engineering, human factors, verification, safety testing, sterilization, packaging validation and contract manufacturing.

Workflows in this category

StarFish Medical is a medical device CDMO providing device design, regulatory affairs, contract manufacturing, and cleanroom assembly services.

Products: ELLA, Pathfinder

Evidence-backed workflow match
Matches Medical Device Contract Manufacturing
“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

Favicon of DCN Dx

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 workflow match
Matches Design Controls & Design History File Support
“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

Rook Quality Systems provides consulting and research services for medical device quality systems, regulatory strategy, clinical studies, and validation.
Evidence-backed workflow match
Matches Design Controls & Design History File Support
“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

Frontage Laboratories is a CRO and CDMO providing bioanalysis, DMPK and ADME studies, toxicology, Phase I support, and drug manufacturing.
Evidence-backed workflow match
Matches Extractables & Leachables Testing
“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

Altasciences is an early phase CRO and CDMO providing toxicology, IND-enabling studies, clinical pharmacology, bioanalysis, and drug manufacturing.

Products: Acceleration Platform

Evidence-backed workflow match
Matches Sterilization Services
“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

Inotiv is a CRO and research models provider offering toxicology, in vivo pharmacology, research and transgenic models, bioanalysis and DMPK.

Products: Teklad, Target Sufficiency +1 more

Evidence-backed workflow match
Matches Biocompatibility Testing
“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

IQVIA is a CRO and technology provider delivering clinical trials, real-world evidence, commercial intelligence and safety operations.

Products: IQVIA Vigilance Platform, SmartSolve +4 more

Evidence-backed workflow match
Matches Human Factors & Usability Engineering
“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