• The Non-BS Manifesto

    The Non-BS manifesto is the cornerstone of all services offered by EnGenius solutions. It enshrines the value set that enables us to strike the optimal balance between efficiency and quality, defined by four principles:

  • Quality Over Proceduralism

    How it has been done is not how it should be done. At EnGenius, excellence is the end-goal and procedures are the means to that end. No box-ticking without a mind for quality. We don’t believe in meaningless procedural steps. Every step must assure quality - or be eliminated.

  • Culture Over Mandate

    The best system flops without culture. Not only that, culture is one of the most efficient tools to leverage in QMS implementation, defined as everyone understanding quality goals in addition to their role in achieving it and committing to achieving said goals.

    This is in sharp contrast to mandating quality. Mandates take resources to enforce but culture is self-enforcing. Mandates set the bar, cultures exceed them. At EnGenius we are dedicated to including a culture of quality in the QMS.

  • Redundancy Over Duplication

    Duplication means extra work: at best, more maintenance; at worst, misalignment. At EnGenius, we believe in system redundancy, not duplicated QMS content.

    We prefer referential over explicit inclusions: if it is captured in one place, point to it but do not duplicate it.

  • Conciseness Over Verbosity

    Words have value. They must be respected as the powerful communication packages they are. Extraneous words add extraneous communication and obfuscate the main message; at best they cause confusion and at worst, miscommunication.

    At EnGenius we believe that fluff has no place in a QMS. A Non-BS QMS is one in which the message is made clear with the least number of words necessary.

General Services

Establish A New QMS

At EnGenius, we create Non-BS QMS procedures tailored to your business and product(s) such that quality and compliance to applicable regulatory requirements are achieved in the least burdensome manner.

Un-BS Your QMS

EnGenius can help your business review and optimize existing QMS procedures in order to improve quality, streamline processes, and lower overall costs. We will review your QMS for duplication, fluff, applicability to business and other optimization opportunities given your business case and product design.

Regulatory Compliance

EnGenius can help with many applicable regulations and standards including:

  • ISO 13485:2016

  • ISO 14971:2019

  • ISO 62366-1:2015

  • ISO 62304:2006+A1:2015

  • ISO 82304-1:2016

  • ISO 14155:2020

  • FDA 21 CFR 820

  • FDA 21 CFR Part 11

  • EU MDR 2017/45

Support Ongoing QMS Commitments

Whether you have an unanticipated staff shortage due to employee turnover or are experiencing a temporary increase in workload, EnGenius can support meeting of your existing QMS requirements in the least burdensome manner possible.

Internal Auditing

Compliance is a cornerstone of every functional QMS and regular internal audits are management system requirements. An EnGenius audit will additionally help you Identify BS in your QMS. Whether you need a formal internal audit or just prefer to have an assessment of your system’s compliance risks, EnGenius can perform a thorough Non-BS audit of your system.

SaMD Services

AI-Enabled Device Consulting

If you are working on an AI-enabled medical device and need help preparing for the regulatory clearance, EnGenius can help you with a range of deliverables such as data governance documents or Pre-Determined Change Control Plans (PCCPs).

Software Development LifeCycle Consulting

Are you looking for an SDLC that is Agile? Are you wanting to release often but the QMS seems to not allow that? Does your system consist of a number of software components of varying degrees of regulatory burden and you want to control each part appropriately?

EnGenius can create a new or improve your existing SDLC to optimally meet your business’ unique demands.

Cyber Security Consulting

Are you looking at an FDA submission or otherwise would like to ensure that your security processes follow industry standards? EnGenius can perform an assessment of your system’s compliance to such state-of-the-art standards as ISO 27001 or ensure compliance to the latest FDA guidances on pre-market and post-market cybersecurity.

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