Customer Success & Professional Services Packages

Get the help you need to navigate the process of designing, developing and launching your product in any regulated medical device market.

Comprehensive and flexible solutions -- backed by a Customer Success team with years of real world experience launching medical devices to market


Support You Need

Get access to resources and expert help for quality assurance, regulatory compliance, audit support, medical device and regulatory staff training, time-saving document packs, part 11 software validation support and more.


Flexible Packages

Packages include regular consulting sessions you can use to tackle challenges you’re currently facing. Whether it’s ensuring an audit goes smoothly, introducing risk management into your entire product lifecycle, or something else entirely -- you’re covered.


Expert Support

An in-house Customer Success Manager (CSM) with all of’s resources at their disposal becomes an extension of your team. Whether you ask for help inside of or by making a phone call, your CSM will help you hit your milestones.

Get help with any of these common, costly and time-consuming challenges you’ll run into as a medical device company

Use your weekly or monthly consultation hours to tackle any of the following challenges preventatively or as they come up.

Quality Assurance

We’ll implement an eQMS that ensures compliance with any regulations your medical device is subject to, while also helping you bring your product to market in less time and with less risk.

      Quality System Design and Implementation
      Launch Pack - Software + procedures, forms and templates
      Training Support
      Quality Strategy
      CAPA Support
      Interim Management
      Gap Analysis
      Training Support
      Mock FDA Inspection

      Regulatory Compliance

      We stay on top of the constant changes made to medical device regulations so that you don’t have to. No matter which markets you operate in, you can trust that our product, team and resources are up-to-date.

      Regulatory Strategy
      Design Control / DHF / Technical File
      Regulatory Submissions
      Gap Analysis
      Project Management & Product Development
      FDA Warning Letter and 483 Observations
      Interim Management
      Risk Management
      ISO Audit Observation / Non-conformance


      We can train your staff in regulatory and quality requirements specific to the type of medical device you produce and markets you operate in. Use this training to manage quality and risk throughout the entire product lifecycle.

      ISO 13485:2016
      Design Controls, FDA 21 CFR Part 820.30
      FDA QSR 21 CFR 820
      CAPA & Complaints
      ISO 14971 Risk Management
      Part 11

      Customer Success & Professional Services Packages

      Get as much (or as little) help as you need to bring a safe and compliant medical device to market in less time.

      Complimentary Services

      When you buy’s eQMS software, you automatically get access to the following at no extra charge:

      • 2-3 one-hour sessions to onboard your team to and train them on the software.
      • Access to a medical device expert is always one click away from within

      Basic Customer Success

      Get everything from the Free Services package, plus monthly consulting sessions, support with mission-critical processes, time-saving documents and more.

      • Dedicated customer success expert to help you get up and running in days not months.
      • Monthly 1-hour consulting sessions that you can use to tackle challenges in quality assurance, regulatory compliance, audit support, staff training, and more.
      • Design Controls and Risk Management support that ensures you’re in compliance with 21 CFR Part 820.30 and ISO 14971. Staff training on regulations may also be included.
      • Software Validation Support - 21 CFR Part 11 IQ/OQ/PQ Qualification Document Packs

      Premium Customer Success

      Get everything from the Free Services and Basic Customer Success packages, plus we’ll become an extension of your team.

      • Weekly 1-hour consulting sessions that you can use to tackle challenges in quality assurance, regulatory compliance, audit support, staff training and more.
      • Dedicated phone support always just a call away when you need it during normal business hours.
      • QMS process checkups to help ensure your processes are compliant and up-to-date -- without slowing you down.

      Schedule your free call to learn more about these services and to have your questions answered.

      Schedule My Free Call
      Next: Learn about Launch Packs for NEW customers that want to get up and running, sooner