Medical Device QMS Consulting

SaMD Specialty

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Maximize Quality.

Minimize Burden.

The Non-BS* Manifesto

The Cornerstone of EnGenius’ Services

Proceduralism

Mandate

Duplication

Verbosity

Quality

Culture

Redundancy

Conciseness

Over

Over

Over

Over

*Burdensome. See FDA Guidance titled “The Least Burdensome Provisions: Concept and Principles.”

Contact Options

  1. Book an appointment here

  2. Fill out the discovery form to tell us more about your business’s needs, or

  3. Use the information below:

ashkon@engeniussolutions.com
(657) 200-1550

555 Anton Blvd, STE 150
Costa Mesa, CA, 92626