For MedTech companies
From data acquisition to post-market monitoring, we bring the operational discipline that turns a novel medical-AI product into a commercial business, without you staffing it yourself.
Services
Eleven service areas in four groups. Open any area for its detailed services, process and deliverables.
Decide whether, where and how to enter the U.S. market, and get the commercial, regulatory and reimbursement groundwork in place.
Strategic consultation for partnership collaboration and integrated solution development for AI startups in the medical space.
Product Screening, Segment Identification, KOL Identification, Architecture Qualification, Predicate Analysis, Executive Consultants, Exploratory Calls, Introductory Partner Calls, In-Person Meetings, Product Demonstrations, Deck Preparation, Meeting Management, Action Tracking, Contractual Agreements, SLA Preparation, Cybersecurity & Data Privacy, Intended Use & Multi-Disciplinary Expertise, Software Engineering & Security Practices, Representative Clinical Datasets, Training & Test Set Independence, Fit-for-Purpose Reference Standards, Model Choice Tailored to Data & Intended Use, Human-AI Interaction Assessment, Performance Testing in Clinical Conditions, Clear, Essential User Information, Post-Deployment Monitoring & Re-training Controls
CPT code identification, custom CPT code analysis, and facilitation for vendor reimbursement requirements.
CPT Code Identification, Custom CPT Code Analysis, CPT Preparation Facilitation
Source and verify clinical data, run evaluations, and take a product from regulatory qualification into a live clinical environment.
Streamlining data acquisition for AI models, managing vendor relationships, and verifying clinical data from stakeholders.
Coordination of clinical and animal lab evaluations for rigorous testing and regulatory alignment.
UPT Process, Evaluation Scheduling, Site Readiness, Equipment Shipping, Shipment Tracking, In-Person Site Support, Re-Shipment
End-to-end technical product deployment support for integration into existing clinical environments.
Build visibility, clinical advocates and channel partners so the product is adopted, not just cleared.
Targeted product promotion in the U.S. through high-profile MedTech conferences and modern social media platforms.
Relationship management and communication with Key Opinion Leaders (KOLs) to drive adoption and credibility.
Quarterly KOL Engagements, KOL Business Networking, Testimonial Mining
Management of distributor networks to optimize supply chains and market reach.
Partner Identification, Exploratory Qualification, Introductory Meetings, Contractual Tracking, Liaison Operations
Keep deployed products running and compliant: support tiers, monitoring, field engineering and complaints.
Dedicated Tier 1 and Tier 2 product support for uptime, rapid troubleshooting and customer success.
Field Engineering (FE) engagements that bridge product development and clinical reality.
FE Tool Identification, T1 & T2 / FE Integration, FE Workflow Closure
Systematic, compliant complaint handling procedures that maintain quality assurance and regulatory standards.
Quarterly Health Checks, T1 Dashboard Monitoring, Critical Onsite Response
How we engage
We work alongside your team across the lifecycle, from research prototype through clinical deployment and post-market review. You can engage for one phase or several.
01 Discover
Candid go/no-go on clinical need, regulatory feasibility and commercial defensibility.
02 Plan
Deployment model, regulatory mapping and change control aligned to your roadmap.
03 Embed
KOL relationships, clinical evaluations, distributor selection and live demos.
04 Operate
24/7 monitoring, Tier 1 and Tier 2 support, complaint handling and field engineering.
05 Improve
Real-world performance monitoring, model retraining controls and quarterly review cadences.
Frameworks
Our deliverables are prepared with these frameworks in mind. Qscription does not certify products or quality systems; certification and clearance decisions rest with the relevant bodies.
Our ten Good Machine Learning Practice pages start with intended use and multi-disciplinary expertise.
Video
Our overview video for AI medical device companies entering the U.S. market.
Watch the videoInsights
Governing the Algorithm · Article 11 of 12
The EU AI Act and the FDA reached similar governance expectations independently. What their convergence means for SaMD companies that sell on both sides of the Atlantic.
Governing the Algorithm · Article 10 of 12
Governing the Algorithm · Article 9 of 12
Tell us where you are and what is in the way. We will tell you plainly which parts we can take on.
Talk to our team