Quality Risk Management Vendors

Quality risk methods, assessments, and programs used in regulated product development, manufacturing, and quality systems.

Related workflows

Rook Quality Systems provides consulting and research services for medical device quality systems, regulatory strategy, clinical studies, and validation.
Evidence-backed capability match
Matches Quality Risk Management
“Rook will work with your company to develop a comprehensive risk management platform for products and processes, including the use of PHAs, FMEAs (process, use, design, and…”
Source: rookqs.com

Also offers: Quality Management System (QMS) Consulting, Medical Device & IVD Regulatory Affairs

Tunnell Consulting is a life sciences consulting firm providing GxP compliance, regulatory strategy, and technology transfer support.
Evidence-backed capability match
Matches Quality Risk Management
“QUALITY MANAGEMENT SYSTEMS, including support for the design and development of an effective QMS, global QMS management, SOP authoring support, QMS optimization, root cause…”
Source: tunnellconsulting.com

Also offers: GxP Compliance Consulting, Technology Transfer, Process Characterization & PPQ, +2 more

Veristat is a specialty CRO providing biostatistics, clinical data management, and regulatory strategy and writing services.

Products: InStat, CoAuthor

Evidence-backed capability match
Matches Quality Risk Management
“Risk assessment and monitoring”
Source: veristat.com

Also offers: Biostatistics & Statistical Programming, Full-Service Clinical Trial Execution (CRO Services), +3 more

Clarkston Consulting is a life-sciences consulting firm providing quality compliance, digital and AI strategy, and transformation services.

Products: Cell Therapy Orchestration Platform (CTOP), Life Sciences Accelerator for S/4HANA

Evidence-backed capability match
Matches Quality Risk Management
“Process Flow / Data Flow Risk Mapping Quality Risk Management”
Source: clarkstonconsulting.com

Also offers: Quality Management System (QMS) Consulting, Transformation, Integration & Change Management, +2 more

Veeva Systems is a life-sciences software and data provider offering CRM, medical information, regulatory, and clinical operations platforms.

Products: Vault CRM, Veeva RIM +6 more

Evidence-backed capability match
Matches Quality Risk Management
“Improve risk visibility across products and processes with a unified approach to risk management.”
Source: veeva.com

Also offers: Life Sciences CRM, Regulatory Information Management (RIM) Platforms, +4 more

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
Matches Quality Risk Management
“StarFish helps clients develop and execute strong verification, validation, and risk management practices that meet global regulatory expectations.”
Source: starfishmedical.com

Also offers: Medical Device Product Design & Engineering, Prototyping & Design for Manufacturing, +2 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 capability match
Matches Quality Risk Management
“Risk Management Comprehensive strategies to mitigate development and manufacturing risks.”
Source: dcndx.com

Also offers: IVD Assay Development, IVD Manufacturing & Scale-Up, +2 more

ProductLife Group is a life sciences consulting and outsourcing group for regulatory affairs, pharmacovigilance, quality and validation, and market access.

Products: D.AI.M.I.

Evidence-backed capability match
Matches Quality Risk Management
“Quality Risk Management, GMP Reviews, Risk Analysis and definition of adaptation plans”
Source: plglifesciences.com

Also offers: Regulatory Development Strategy & Agency Interactions, End-to-End Pharmacovigilance Outsourcing, +6 more

Compare listed vendors

VendorDelivery modelAlso offersIn their words
Clarkston ConsultingConsulting / Advisory FirmComplaint Handling & Nonconformance Management, GxP Compliance Consulting“Process Flow / Data Flow Risk Mapping Quality Risk Management”clarkstonconsulting.com · reviewed Oct 21, 2026
DCN DxCDMO / CMO—“Risk Management Comprehensive strategies to mitigate development and manufacturing risks.”dcndx.com · reviewed Oct 21, 2026
ProductLife GroupService ProviderGxP Compliance Consulting, GMP Manufacturing Compliance Support, GCP & Clinical Quality Compliance, QP Services & Batch Certification“Quality Risk Management, GMP Reviews, Risk Analysis and definition of adaptation plans”plglifesciences.com · reviewed Oct 26, 2026
Rook Quality SystemsConsulting / Advisory FirmComplaint Handling & Nonconformance Management, GCP & Clinical Quality Compliance“Rook will work with your company to develop a comprehensive risk management platform for products and processes, including the use of PHAs, FMEAs (process…”rookqs.com · reviewed Oct 20, 2026
StarFish MedicalCDMO / CMO—“StarFish helps clients develop and execute strong verification, validation, and risk management practices that meet global regulatory expectations.”starfishmedical.com · reviewed Oct 21, 2026
Tunnell ConsultingConsulting / Advisory FirmGxP Compliance Consulting, GMP Manufacturing Compliance Support, GCP & Clinical Quality Compliance“QUALITY MANAGEMENT SYSTEMS, including support for the design and development of an effective QMS, global QMS management, SOP authoring support, QMS…”tunnellconsulting.com · reviewed Oct 21, 2026
Veeva SystemsSoftware / Technology PlatformComplaint Handling & Nonconformance Management“Improve risk visibility across products and processes with a unified approach to risk management.”veeva.com · reviewed Oct 20, 2026
VeristatCRO / Research Services ProviderComplaint Handling & Nonconformance Management, GxP Compliance Consulting, GMP Manufacturing Compliance Support, GCP & Clinical Quality Compliance, QP Services & Batch Certification“Risk assessment and monitoring”veristat.com · reviewed Oct 26, 2026