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K2C Product

One connected platform. A modular approach.

Explore platform architecture, governance, security and the flexible adoption model.

Explore the Product →
Platform Overview →Modular governance and quality management for Life Sciences.Modular Architecture →Start with a priority process and extend over time.Security & Auditability →Access, controlled workflows, audit trails and records.Plan Your Implementation →Talk through an initial scope and rollout priorities.
K2C Solutions

Quality capabilities around your priorities.

Six complementary capability families, connected by shared governance.

Explore All Solutions →
Quality Management →SOPs, training, changes, issues, CAPA and quality plans.Audit & Supplier Quality →Qualifications, supplier audits, process audits and findings.Clinical Quality & GCP →Clinical studies, audits, TMF and IIS.Pharmacovigilance & Safety →PSMF, PV agreements and SAE/SUSAR processes.Laboratory & Technical Operations →Notebooks, analytical methods and technical reports.Medical & Regulatory Affairs →Medical inquiries and marketing materials.
About K2C

Quality governance. Lasting partnership.

Learn about K2C and connect with our team to discuss your quality priorities.

Discover K2C →
About K2C →Our approach to modular governance, implementation and customer enablement.Contact →Book a Discovery Session and discuss your quality priorities.
ProductPlatform OverviewModular ArchitectureSecurity & Auditability
SolutionsAll SolutionsQuality ManagementAudit & Supplier QualityClinical Quality & GCPPharmacovigilance & SafetyLaboratory & Technical OperationsMedical & Regulatory Affairs
IndustriesServicesWhy K2C
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ACROSS MEDICAL DEVICE QUALITY PROCESSES

Clearer Control

Medical device quality teams need to coordinate controlled information and follow-up work across internal functions and suppliers. When these activities sit in separate systems, it can be difficult to see the status of a change, the actions arising from an audit or the history of a quality issue.

Medical device quality depends on clear links between controlled information, supplier oversight, changes, quality issues and resulting actions. K2C helps bring those records into a more connected and traceable environment.
K2C

Priority quality processes

Explore the processes K2C Solutions can support within a shared governance model.

01

Document and training control

Work from approved information and align competence with responsibilities.

02

Change, quality issues and CAPA

Follow decisions, actions, evidence and closure in context.

03

Supplier quality and audits

Organise qualification, oversight, findings and follow-up.

04

Technical and laboratory records

Govern methods, notebooks, reports and related evidence.

05

Management visibility

See ownership, status, ageing and open actions across quality work.

K2C

Three practical visibility improvements

01

1. Link findings to actions

Trace what arose from an audit or supplier review and who owns the follow-up.

02

2. Follow changes end to end

See initiation, review, approval, implementation and related evidence.

03

3. See CAPA in context

Connect the issue, plan, actions, evidence and effectiveness follow-up.

K2C

Discuss Your Medical Devices Quality Priorities

Tell us which quality processes create the most friction today.

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