Medical Device & Healthcare CPQ

Quote medical devices and surgical kits with compliance built in.

Medical device sales teams lose deals to slow quoting, wrong kit configurations, and compliance documentation that isn't ready when the customer asks. ServiceCPQ handles configure-price-quote for medical devices, surgical kits, and hospital equipment — with CE, FDA, and MDR compliance flags embedded in the configuration logic.

4 portalsHospital, dealer, distributor, direct
CE/FDA/MDRCompliance in configuration logic
Kit CPQSurgical kit & procedure tray config
90 daysPilot to production
Quote compliance check — live QT-2025-MED-0094
CE Mark — all kit components
MDR 2017/745 · Class IIa
Passed
FDA 510(k) clearance
US market · device classification II
Cleared
!
GPO contract pricing
Vizient contract · check eligibility
Review
IFU document pack
Instructions for use · auto-attach
Auto
ISO 13485 QMS compliance
Manufacturing quality · certified
Verified
UDI traceability
Unique device ID · all line items
Tagged
The real problem

Medical device CPQ is different. Generic platforms don't handle it.

Standard CPQ platforms were built for industrial products or software subscriptions. Medical devices have regulatory compliance embedded in the configuration, kit and tray assembly logic, multi-tier hospital channel pricing, and clinical evidence requirements at the quote stage. None of that is handled out of the box by SAP CPQ, Salesforce CPQ, or generic quoting tools.

Compliance not embedded in configuration
Sales reps configure a kit and only discover the regulatory issue at submission. CE marks, FDA clearance, and MDR classification need to be in the configuration rules — not a manual checklist at the end.
Surgical kit and tray CPQ is unstructured
Kit configuration is manual spreadsheet work. Components change per procedure type, sterility requirement, and hospital preference. No CPQ platform handles kit assembly logic with regulatory tags per line item.
Hospital, GPO, and distributor pricing is fragmented
Hospital systems have GPO contracts. Distributors have their own tiers. Direct channel has a different price book. Managing these in one quote without a multi-portal architecture creates pricing errors and compliance risk.
Service contract quoting is disconnected from device
Capital medical equipment (imaging, diagnostics, surgical robotics) requires service contracts, warranty packages, and preventive maintenance programs. These are quoted separately from the device — losing bundling revenue and margin.
What ServiceCPQ covers

Every medical device quoting scenario. One platform.

Medical device and healthcare CPQ spans capital equipment, consumables, surgical kits, and service contracts. ServiceCPQ handles all four from a unified product and compliance object.

Capital Equipment CPQ
Configure imaging systems, diagnostic equipment, surgical robots, and hospital infrastructure. CTO and MTO modes, compliance flags, and service contract bundling at the quote stage.
CTOMTO Service bundleCE/FDA
Surgical Kit & Tray CPQ
Procedure-based kit configuration. Select components by surgical procedure, sterility level, and hospital preference. Compliance tags per line item. UDI traceability across the full kit BOM.
Kit configProcedure-based UDIMDR
Consumables & Supplies CPQ
Ongoing consumables, reagents, disposables, and procedure packs. Multi-tier pricing across hospital systems, GPO contracts, and distributor channels. Repeat order configuration and contract pricing.
GPO pricingContract DistributorRecurring
Service Contract CPQ
Preventive maintenance, full-service, and time-and-material contracts for capital equipment. Extended warranty packages. Service scope linked to device configuration and regulatory class.
PM contractsWarranty T&MCapital equip.
Tender & RFQ Response CPQ
Hospital tender and government procurement responses. Multi-product, multi-line quote with compliance documentation auto-attached. Version control and approval workflow for complex submissions.
TenderGovt. procurement Compliance docs
Instrument Reprocessing & Lifecycle
Instrument set reprocessing contracts, lifecycle management, and sterilisation service quoting for surgical instruments. Tracks instrument sets through repair, recertification, and loaner management.
LifecycleReprocessing Sterile services
Surgical kit configurator

Configure a surgical kit by procedure. Compliance checked line by line.

The surgical kit configurator selects components by procedure type, patient profile, and sterility requirement — with CE/FDA compliance status and UDI reference on every line item. Hospital-specific preference lists applied automatically.

Procedure-based configuration logic
Select the procedure type and patient profile — the configurator populates the kit from procedure-specific component rules, not a blank pick list.
Compliance status per line item
Each BOM line carries CE mark, FDA clearance, and MDR classification. Non-compliant combinations blocked before the quote is generated.
Hospital preference list integration
Apply a hospital's preferred instrument brands and specifications as a filter layer over the base configuration. One kit template, many hospital-specific variants.
UDI and IFU auto-attached to quote
Unique Device Identifiers and Instructions for Use documents are automatically attached to the quote output. No manual compliance document assembly.
servicecpq — surgical kit configurator
Procedure type
Laparoscopic cholecystectomy Hip arthroplasty Cardiac bypass
Sterility requirement
Steam autoclave Gamma irradiation Single-use / sterile pack
Additional instruments
Clip applicator Irrigation set Haemostasis forceps Specimen retrieval bag Extended trocar set
Kit BOM — compliance verified ● 7 lines · UDI tagged
LR-LAP-TCAR-55mm trocar, bladed tip×3CE
LR-LAP-TCAR-1212mm trocar, optical entry×1CE
LR-LAP-GRAS-AAtraumatic grasper, 5mm×2FDA
LR-CLIP-APP-10Clip applicator, 10mm medium×1CE
LR-IRR-SET-LIrrigation/suction set, 5mm×1ISO
Kit price
€2,840
Per kit · hospital contract pricing
Compliance
5/5 ✓
IFU auto-attached
Platform capabilities

Built for medical device sales. Not adapted from it.

Every capability in ServiceCPQ for medical devices was designed around the regulatory, channel, and configuration complexity that generic CPQ platforms paper over.

Compliance-embedded configuration
CE, FDA, MDR, and ISO compliance status embedded in configuration rules. Non-compliant combinations blocked. Compliance pack auto-generated with every quote.
Surgical kit & tray builder
Procedure-driven kit configuration with component-level compliance tags, UDI tracking, sterility classification, and hospital preference list overlay.
Multi-portal architecture
Separate quoting portals for hospital procurement, GPO members, distributors, and direct sales. Different price books, access controls, and compliance requirements per portal.
GPO & contract pricing
Vizient, Premier, Healthtrust, and custom GPO contract pricing applied automatically based on the buying entity. Contract eligibility verified at quote time.
AI parts & device matching
NLP-driven device and component matching. Cross-reference across catalogues, equivalent devices, and superseded product numbers. UMAP-powered similarity scoring.
IFU & technical doc auto-attach
Instructions for use, declaration of conformity, and clinical evidence documents auto-attached to the quote based on the configured device and market destination.
Capital equipment lifecycle
Equipment quote chains into service contract, preventive maintenance, and warranty at handover. Full asset lifecycle object from first sale to end of service.
Multi-market & multi-currency
Different compliance requirements per market destination — EU MDR, US FDA, ANVISA, TGA, PMDA. Multi-currency price books with market-specific regulatory configuration rules.
Channel architecture

Four portals. One platform.

Medical device distribution is multi-tier — direct sales, national distributors, regional dealers, and hospital procurement all need different quoting experiences. ServiceCPQ's multi-portal architecture serves all four from one product and compliance master.

Portal 01
Hospital & IDN Procurement
Hospital systems and integrated delivery networks quote against their specific contract pricing, with compliance documentation and clinical evidence attached automatically.
  • IDN and hospital-specific pricing
  • GPO contract eligibility check
  • Compliance pack per quote
  • Multi-site order consolidation
Portal 02
Distributor Portal
National and regional distributors configure, price, and quote independently. Tiered distributor pricing, territory access controls, and sub-distributor management.
  • Distributor price tiers and margins
  • Territory and access controls
  • Quote-to-order submission
  • Inventory visibility integration
Portal 03
Clinical Sales Rep Portal
Field reps quote at the bedside or in theatre using mobile-ready configurations. Approval workflow for non-standard pricing. Quote history and follow-up tracking per account.
  • Mobile-optimised configuration
  • Custom pricing approval workflow
  • Account and opportunity tracking
  • Clinical evidence library access
Portal 04
Direct & eCommerce
Direct-to-hospital and clinic online ordering with self-service configuration, real-time compliance status, and order submission without a sales rep in the loop.
  • Self-service configuration
  • Real-time compliance status
  • Registered user account pricing
  • Order confirmation and tracking
Regulatory compliance

Compliance isn't a checklist. It's embedded in the configuration.

Every device in your catalogue carries its regulatory attributes — CE class, FDA clearance number, MDR risk classification, UDI. The CPQ configuration logic uses these attributes to prevent non-compliant quotes from ever being generated.

Market-destination rules enforce the right compliance framework automatically. Quoting an IVD device for the EU market triggers MDR/IVDR rules. Quoting for the US triggers FDA classification checks. Your sales team doesn't need to know the difference.

CE MDR
EU Medical Device Regulation
MDR 2017/745 and IVDR 2017/746 compliance embedded in device classification. Risk class I–III configuration rules. DoC auto-generated per market destination.
FDA 510(k)
FDA Device Classification
Class I, II, III classification attributes on every device. 510(k) clearance numbers attached to quote lines. PMA requirements flagged for Class III configurations.
ISO 13485
Quality Management System
ISO 13485 QMS certification status tracked per device and per manufacturer. Certificate validity and scope displayed at quote stage and attached to compliance pack.
UDI
Unique Device Identification
UDI-DI and UDI-PI attributes on every line item in the BOM. Traceability across kit assembly, distribution, and patient use. EUDAMED and FDA GUDID integration.
Competitive positioning

ServiceCPQ vs generic CPQ for medical devices

Generic CPQ platforms require extensive custom configuration to handle medical device compliance, kit assembly, and multi-portal channel requirements. ServiceCPQ handles these natively.

CapabilitySalesforce CPQ / SAP CPQ / GenericServiceCPQ
CE/FDA/MDR compliance in configuration logic Requires custom fields and manual validation rules Native compliance attributes embedded in product and config objects
Surgical kit and tray CPQ No procedure-based kit assembly logic out of box Procedure-based kit configurator with compliance per line item
Multi-portal architecture (hospital / distributor / direct)~ Possible with multiple licence tiers and custom portal build Native 4-portal architecture, different pricing and compliance rules per portal
GPO contract pricing auto-applied~ Requires CRM integration and custom pricing waterfall build GPO contract eligibility checked and pricing applied at configuration
IFU and compliance doc auto-attach Manual document management, not tied to product configuration Documents auto-attached based on device, market, and regulatory class
UDI traceability across kit BOM No native UDI object or kit-level traceability UDI-DI and UDI-PI on every BOM line, kit and assembly level
Service contract from device quote~ Requires separate service cloud or field service integration Service contract, PM programme, and warranty bundled at quote stage
Deployment timeline 12–24 months with medical device customisation 90-day paid pilot scoped to your device family and channel
Device coverage

Every category of medical device and healthcare equipment.

Surgical instruments Surgical robotics Laparoscopic equipment Diagnostic imaging In-vitro diagnostics (IVD) Orthopaedic implants Cardiovascular devices Wound care & dressings Single-use procedure packs Hospital infrastructure Patient monitoring Infusion & drug delivery Sterilisation equipment Dental equipment & supplies Rehabilitation & mobility Ophthalmology devices Endoscopy systems Point-of-care diagnostics
Start with a pilot

Quote medical devices with compliance, not after it.

We configure a working demo against your actual device catalogue — your kit types, your channels, your compliance requirements. 45 minutes. You see exactly what your clinical sales team and distributors would use.

Or email: ashok@servicecpq.com · 90-day paid pilot · Scoped within 2 weeks