Our Core Services

Quality Management Systems (QMS):

Develop, optimize, and maintain ISO 13485 and FDA 21 CFR 820-compliant systems tailored to your product lifecycle.

Regulatory Compliance:

Strategic support for compliance with FDA, EU IVDR, Health Canada, MDSAP, and other global regulatory requirements.

Auditing Services

Internal audits, supplier audits, gap assessments, and mock inspections to ensure audit readiness.

Design Controls:

End-to-end support in establishing and documenting design inputs, outputs, verifications, validations, DHF and DMR management.

Risk Management:

Implementation of ISO 14971-compliant processes for product and process risk assessment and mitigation.

Validation & Qualification:

Guidance on IQ/OQ/PQ, method validation, process validation, and software/system validations to ensure compliance and reproducibility.

Inspection Readiness & Remediation:

Tailored support for FDA, Notified Body, and similar inspections—including CAPA, 483 responses, and strategic remediation.

Industries We Serve

Medical Devices:
Class I, II, and III device support for QMS, regulatory submissions, and lifecycle compliance.

In Vitro Diagnostics (IVDs):
Specialized expertise in IVDR, CLIA, and global diagnostic regulations, from reagents to instrumentation.

Molecular Diagnostics:
Guidance for emerging technologies involving LDTs, companion diagnostics, and software-as-a-medical-device (SaMD).

Combination Products:
Consulting for devices containing drugs or biologics, including risk classification and regulatory strategy.

Contract Manufacturers & Suppliers:
Supplier auditing, quality agreements, and compliance alignment for outsourced manufacturing networks.

Meet the Founder

Jason Erickson is a seasoned quality and regulatory affairs executive with over 20 years of experience in the medical device and in vitro diagnostic (IVD) industries. As the founder of AssuraPath Consulting, he specializes in helping organizations develop and optimize global Quality Management Systems (QMS), navigate complex regulatory landscapes, and ensure audit readiness across all stages of the product lifecycle.

Jason’s career spans leadership roles in both startup and multinational environments, where he has built and led high-performing teams and driven compliance initiatives across FDA QSR, ISO 13485, MDSAP, IVDR, and other global frameworks. His approach is grounded in clarity, partnership, and pragmatic execution.

Jason is passionate about helping companies move from reactive compliance to proactive quality culture. His consulting practice supports clients at all stages—from startups launching their first device to global firms navigating regulatory change.