ITEKO Inc.
Regulatory Affairs and Quality Assurance for Medical Devices
ITEKO Inc. supports medical-device manufacturers, importers, and distributors with regulatory strategy, submission preparation, quality systems, and ongoing RAQA support. We help translate regulatory requirements into practical plans and clearly documented deliverables.
What We Do
ITEKO provides focused regulatory and quality support across the device lifecycle. Each engagement is scoped to your specific requirements.
01
Regulatory Strategy and Submission Support
Clarify applicable requirements and develop a practical plan for market access—covering classification, pathway assessment, and submission preparation.
02
FDA 510(k) Support
Support predicate research, substantial equivalence strategy, eSTAR preparation, and responses to FDA requests for additional information.
03
Canadian Licensing and MDEL Support
Assist with Medical Device Licence and Medical Device Establishment Licence applications, importer and distributor procedures, and Health Canada inspection support.
04
Quality Systems and Inspection Readiness
Develop quality-system documentation, conduct gap assessments and internal audits, and prepare for regulatory inspections and certification audits.
05
Fractional RAQA Leadership
Provide regulatory and quality leadership on a part-time or project basis—covering priorities, oversight, issue review, and implementation follow-through.
Who We Work With
ITEKO works with organizations that need experienced RAQA support for a defined project or ongoing engagement.
- Medical device manufacturers seeking market authorization in Canada or the United States
- Importers and distributors managing licensing obligations under the Medical Devices Regulations
- Health technology companies building or maturing their quality management systems
- Organizations preparing for regulatory inspections or third-party audits
- Teams that need fractional RAQA leadership during growth, transition, or a defined project
How Engagements Work
Every engagement begins with a clear understanding of your device, your market, and your objective. Work is scoped and agreed before it starts.
01
Understand
We start by understanding your device, intended use, and business objective — not with a generic checklist.
02
Assess
We review applicable requirements, existing documentation, and any evidence gaps relevant to your submission or system.
03
Scope
We agree on a defined work plan — deliverables, timeline, and responsibilities — before work begins.
04
Execute
We produce documented, reviewable work: strategies, submissions, procedures, and decisions your team can rely on.