What we Do
NDC Global is a consulting and advisory firm specialising in Digital Health and Software as a Medical Device (SaMD) for the Life Sciences sector. We are a consortium of MedTech and SaMD experts dedicated to guiding our clients through the five pillars of Digital Health, from innovation to commercialisation.
Our team brings extensive industry experience, having previously worked within MedTech companies to establish Digital Health and SaMD capabilities, and developing concepts into viable products ready for clinical validation, regulatory approval, and reimbursement.
Unlike traditional consulting firms, we seamlessly integrate into your digital health team, manage your entire digital capability, or offer targeted advisory services across the five pillars as needed.
Commercial & Product Innovation
The success of Digital Health innovation hinges on three critical factors: evaluating product ideas, planning the product roadmap for early regulatory approval, and developing a product marketing strategy. We help our clients identify the most promising products and develop a roadmap that facilitates a smooth transition from development to a regulated and commercially viable product. Our refined process ensures a rigorous and effective product strategy.
Clinical Support
Clinical Advisory - We can support or fill your CMO role, and provide expert clinical and human factor’s input for product development.
Clinical Study Management - Our clinical team can support clinical study / trial setup with respected UK and US institutes.
Clinical Validation - Review / create clinical validation protocol’s. Design / manage clinical pathway for PoC and clinical validation. Assist in assembling the clinical validation tech file.
Clinical Annotation - Define Annotation process & deliver annotations for AI data model and clinical validation process.
Product Development
Development Methodology - We can design and implement a staged gate hybrid agile model with adherence to ISO 13485 and IEC 62304 standards.
Product Build - If you require to outsource the solution development part, we have partnered with several Digital Health solution developers whom have a regulated QMS platform and relevant experience in Digital Health / SaMD / AI model product development.
Regulated Platform - Our Solution Architects can design a compliant platform to host the solutions covering; business logic, mobile app framework, secure API’s, data lake, AI platform and infrastructure. We will manage the build and testing of the platform on either GCP or AWS platforms.
Programme Management - Our programme Managers will manage your internal team and suppliers against an agreed programme plan and budget. We provide online project plans and management reporting capabilities so you know the status at all times.
Regulatory Affairs and Quality Management
Regulatory Roadmap - We advise on your product portfolio and develop a regulatory plan for regulatory submission by regional governing body.
Clinical Evaluation - We can assist in reviewing / drafting clinical evidence, evaluation plans and reports required for submission.
Regulatory Documentation - Our team review and provide feedback on documentation and assist in drafting the full set prior to submission. We can assist in Q sub requests and meeting planning, and in software verification and validation.
QMS - Our Quality team carry out a full review of your SOP’s, MDF’s, technical files, and systems to ensure compliance. We can assist in QMS and ALM solution selection and contractual negotiations.
Data Management & AI / ML Models
Data Management - We assist in drafting data requirements (specific to regulatory region), and sourcing the appropriate quality of data from global providers. Data can be sourced for AI model training, Clinical Study’s and Clinical Validation.
Data Annotation - We support our Client’s in assessing current annotation practices, designing advanced annotation strategies and managing the annotation process with Clinicians.
AI / ML Model Development - Our AI team have experience in innovative model design and build. All of our model designs run through a PoC prior to approval and full model build. We constantly evaluate the performance and accuracy of the model against the standard of truth.
Data Monetisation - We can advise on a data monetisation strategy and manage introductions with interested parties.
NDC Global 2025 - Unit 6, Cherrytree Farm, Blackmore End Road, Sible Hedingham, CO9 3LZ
Registered in England - 08529430 ©Copyright. All rights reserved.
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