For any stage of your product development lifecycle

Stage-Appropriate Regulatory Support

While Nemedio believes in starting compliance activities as early as possible, we’re also sensitive to your resources and needs at various stages of your company and product’s lifecycle. Because of this, Nemedio has created different service packages catered to your current stage of development.

What is your current state of compliance?

Please select below.
Please select below.

Starter Precompliance Package

Designed for companies at the earliest stages of R&D activities in order to create a full set of requirements that guide product development, ensuring you build the right device, the first time.
  • Software access to Nemedio's Compliance Tools platform: noQS License
  • Expert assessment with a corresponding summary report of your existing product documentation, which will provide feedback and recommendations to improve your Design History File
  • Special guidance for non-standard products

Precompliance Quickstart Program

Our unique program couples your team's existing engineering and R&D efforts with phase-appropriate regulatory and quality management activities. These activities are then paired with our Product Lifecycle Management (PLM) Software Tool to form a foundation for smooth transition to a compliant Quality Management System (QMS) and Design History File (DHF) when your team is ready to begin clinical testing.
  • Software access to Nemedio's Compliance Tools platform: preQS License
  • Expert assessment with corresponding summary reports of your existing quality system, software architecture (if applicable) and initial list of parts and suppliers
  • Review of your device description and usage instructions
  • Regulatory analysis and planning
  • Generation of design inputs
  • Test planning
  • Q-Submission meeting preparation
  • If your product contains a drug component: Target Product Profile (TPP) Identification and Classification of TPPs into Quality and Labeling TPPS
  • Additional add-on activities include: Standards Analysis & Requirements Derivation, Failure Modes and Effects Analysis (FMEA) Support, Human Factors Engineering Planning

Compliance Transition Program

Designed to support companies transitioning from Precompliant activities to Compliant activities by providing products and services to make the process as seamless and straightforward as possible.
  • Software access to Nemedio's Compliance Tools platform: coreQS and designQS License
  • Standard operating procedure (SOP) setup
  • Software validation kit
  • Guided validation execution and SOP approval
  • If you already have a quality system in place, we'll provide strategic and hands-on migration support
  • Additional add-on activities include: SOP customization

Retained Premarket Support

After the Quality System has been established, you’re ready to start using it to finish documenting your Design History File and other company activities. The majority of these materials were started during the Precompliance portion of your journey, but now that your team has transitioned to full compliance by doing the above Compliance Transition Program, these activities will continue as you work towards the refinement and completion of your product for submission.
  • Design and development planning
  • Supplier qualification and quality agreement negotiation
  • DHF records creation
  • Validation and verification protocols generation
  • Test lab management and oversight
  • Manufacturing records creation
  • Design transfer to manufacturing

Add-on Consulting Services

In addition to the packages above, we offer the following services to further support your compliance journey.
Training and Workshops
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Quality Team Vetting & Placement
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Clinical Trial Strategy and Program Support
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