9X Medical Compliance & Consulting

When clinics face shortages, price increases, or vendor issues, switching solutions can create compliance gaps. We help you review and source alternative equipment and medication options while keeping procurement and documentation aligned with FDA expectations and industry best practices.

What we do:

• Identify viable alternatives based on your operational requirements
• Validate suppliers and product documentation before purchase
• Produce an audit-ready decision file for internal approvals

1. Equipment alternatives (devices, consumables, clinical equipment)
   • Requirements mapping (use environment, compatibility, constraints)
   • Supplier credibility screening (authorized channels, reliability signals)
   • Documentation readiness check: labeling/IFU availability, traceability details, safety notices/recalls, service & maintenance terms
   • Operational readiness: staff training needs, implementation steps, support model
2. Medication alternatives (compliance + sourcing support)
   • Shortage-driven alternatives workflow support (process and documentation)
   • Supplier legitimacy screening (licensed sources / authorized distribution pathways)
   • Storage/handling/logistics alignment (temperature control where relevant)
   • Documentation pack for internal approval (what was reviewed, why selected, what controls apply)

We support the compliance and sourcing process. The final clinical decision regarding medication selection/substitution remains with the clinic’s licensed clinician and/or pharmacist according to local rules and clinical judgment.

We can negotiate with suppliers and purchase on your behalf, ensuring pricing, delivery terms, and documentation meet your internal requirements – while maintaining an audit-ready quality assurance trail.

What’s included:

• Supplier outreach and negotiation (price, lead times, warranties, SLAs, returns)
• Procurement execution on your behalf (PO support, order coordination, delivery tracking)
• QA checks before purchase: documentation completeness + vendor credibility screening
• Receiving/acceptance checklist (what to verify on arrival)
• Traceability record keeping (what was bought, from whom, when, with which documentation)

Quality assurance safeguards:

• Approved-supplier criteria + red-flag screening
• Documentation checklist enforced before payment/release (as applicable)
• Change control when switching suppliers/products
• Recall/safety notice monitoring during the engagement

1. Discovery & Intake: scope, risks, constraints, timelines
2. Assessment: documentation review + stakeholder interviews (and high-level technical review where relevant)
3. Findings & Roadmap: prioritized plan with clear owners and timelines
4. Implementation Support: help execute controls, vendor governance, and documentation
5. Ongoing Advisory (optional): governance cadence, periodic checks, ongoing improvement

• Executive summary and risk overview
• Compliance roadmap (prioritized action plan)
• Policy pack (editable templates)
• Data flow diagrams and data inventory
• Vendor screening results and documentation checklist
• Audit-ready evidence pack structure + checklists
• Training deck + attendance tracking guidance
• Remediation tracker (Jira/Excel compatible)
• Alternatives comparison matrix (requirements vs options)
• Decision record for internal approvals (evidence-based)

• Vendor can’t provide required documentation or fails internal checks
• Medication shortages require a rapid, compliant alternative pathway
• New clinic/site expansion requiring standardized suppliers and processes
• Preparing for payer/partner audits and needing documented procurement controls

• We provide compliance and procurement advisory for clinics and providers.
• We do not provide medical diagnosis, treatment, or prescribing services.
• Clinical decisions remain with the client’s licensed clinicians/pharmacists.
• Purchasing is performed as your authorized agent and under your internal approvals.