IT Services for Regulated Manufactures Learn More Quality Services for Regulated Manufactures Learn More

Achieve compliance, prepare for and pass audits, and implement smarter systems.

Immune can help you meet quality assurance requirements, satisfying the needs of regulators and customers.

Medical Device

The quickest way to achieve compliance with the Medical Device Single Audit Program is through the implementation of modern automation.

The quickest way to implement automation is through a single turn-key consulting team.


Immune helps customers manage complex product material bills and product batches through electronic control of components and costs.

Enterprise Resource Planning (ERP) continues to be more accessible and readily validated.

Quality Assurance Consulting

Effective Quality Management Systems are repeatable, efficient, and streamlined.

We help customers analyze, design, and implement programs to meet CA-FBD, US FDA 21 CFR part 11, 58, 210, 211, 820; ISO 9001, 13485, 14971, 17025; JPAL; ANVISA; TGA; or CMDR

Regulatory Affairs Consulting

Regulatory support makes or breaks product launches.

Immune helps companies interface with regulatory agencies, satisfy reporting requirements, build device records and histories, complete submissions, obtain certificates and clearances, and develop programs that ensure lasting success.

Software System Implementation

Only software systems held to a high requirement can help pass requirements.

Immune helps customers implement software systems for regulated manufacturing, including Electronic Quality Management Systems (EQMS) in a turn-key fashion complete with validations and IOQs.

Contact Us


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Choose carefully. We specialize in consulting for life sciences. Our expertise lets us pick a great ERP or EDMS, a great operating server platform, and a future-proof infrastructure.


A system is as ROI does. Decision makers select, plan, and implement systems that grow sales and increase quality of life for company employees. Quantifiable gains rest easy with leadership.


Immune employs Exemplar Global certified auditors and consultants, and Microsoft certified technology consultants. Immune is a Microsoft Partner and value added re-seller for EQMS systems.