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
Book an appointment here
Fill out the discovery form to tell us more about your business’s needs, or
Use the information below:
ashkon@engeniussolutions.com
(657) 200-1550
555 Anton Blvd, STE 150
Costa Mesa, CA, 92626