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Every agreement. Every device.

Medical device agreements govern the product development, manufacturing, commercial, and regulatory relationships behind every device. Make every agreement perform.

Key Benefits
Use Cases
How We Deliver
Resources
Icertis in Action

Strengthen product development

Manage clinical investigation, technology collaboration, engineering services, and IP licensing agreements to support product innovation.

Build supply chain resilience

Manage contract manufacturing, component supply, supplier quality, and sterilization agreements to strengthen supply continuity.

Accelerate commercialization

Connect Group Purchasing Organization (GPO), Integrated Delivery Network (IDN), distributor, and channel partner agreements to bring products to market faster.

Regulatory confidence, built in

Track FDA, European Union Medical Device Regulations (EU MDR), ISO 13485, and post-market surveillance obligations across global markets.

Product development

Centralize product development agreements to strengthen execution from design through clinical evaluation and launch.
  • Manage joint development, technology collaboration, engineering services, clinical investigation, and IP licensing agreements.
  • Track development milestones, engineering changes, ownership rights, and partner commitments across product development.
  • Surface milestone changes, contractual dependencies, and development obligations before they delay product development.

Manufacturing & supply chain

Centralize manufacturing and supplier agreements to strengthen production readiness and supply continuity.
  • Track contract manufacturing, component supply, supplier quality, and sterilization agreements across manufacturing partners.
  • Monitor delivery commitments, quality requirements, engineering changes, and service levels before production schedules are affected.
  • Identify supplier obligations, quality exceptions, and delivery dependencies before they disrupt production or supply continuity.

Commercial operations

Connect commercial commitments to strengthen commercial execution.
  • Manage GPO, IDN, distributor, and channel partner agreements across complex healthcare sales channels.
  • Ensure negotiated pricing terms, territory rights, rebates, and channel obligations are consistently executed.
  • Surface pricing changes, renewal opportunities, and commercial commitments before they impact product launches and growth.

Compliance & audit readiness

Manage quality and regulatory commitments across products, markets, and global jurisdictions.
  • Map FDA, EU MDR, ISO 13485, and post-market surveillance requirements to specific contract obligations.
  • Respond to regulatory changes with visibility into every affected product, manufacturing, supplier, and commercial agreement.
  • Maintain audit-ready documentation across global regulatory requirements without manual tracking.

How Icertis Delivers

Move from contract creation to compliance to insight, without gaps.

Resources

Insights for Asset Management contract and compliance leaders.

Browse Library

Join 400+ enterprises who've made contracts their competitive advantage.

See Icertis in Action

See how Icertis Contract Intelligence connects agreements, data, and systems across your medical devices organization.

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