Speed, scale and structure
- Research and retrieval
- Information structuring
- Draft development
- Consistency checks
Regulatory intelligence for medical technology
Regulatory expertise for medical software and AI
MDRC aligns technology, evidence and regulatory requirements into one defensible pathway for medical software, AI-enabled healthcare solutions, software-driven devices and IVD products.
Technology
software · AI · devices
Evidence
clinical · performance
Lifecycle
control · change · PMS
Regulation
MDR · IVDR · FDA
MDRC
expert regulatory judgment
One product system · one regulatory direction
What MDRC supports
One framework across the regulatory lifecycle
We connect the decisions, evidence and controlled processes that must remain consistent from product definition through market access and post-market change.
01
Regulatory strategy
Qualification, classification and pathway planning
↗02Technical documentation
A connected evidence system built for assessment
↗03Software lifecycle compliance
IEC 62304 processes, records and change control
↗04Clinical and performance evaluation
Evidence, claims and benefit–risk justification
↗05Risk management
ISO 14971 connected with software and cybersecurity
↗06Quality management systems
ISO 13485 architecture for day-to-day development
↗07Post-market surveillance
Signals, evidence and lifecycle feedback
↗08FDA and US market access
US planning for software-centred technologies
↗Technologies
Start with the product you are developing
Different technologies create different regulatory questions. Each route begins with intended purpose, architecture, risk and clinical role.
PRODUCT LANDSCAPEREGULATORY DIRECTION
01
MDSW / SaMDMedical software
Standalone applications, clinical software and digital therapeutics
Explore technology ↗02
AI / EMERGINGAI and emerging technologies
Models, data governance, autonomy and controlled change
Explore technology ↗03
CONNECTED / PHYSICALMedical devices and equipment
Physical products with embedded or connected software
Explore technology ↗04
IVD / LABORATORYIn vitro diagnostics
Analysers, algorithms and digital laboratory workflows
Explore technology ↗AI and expert work
Different roles. One regulatory workflow.
AI is helpful, but it is not a substitute for regulatory expertise. The two are most powerful when they work together in different parts of the same expert-directed process.
Expert-directed
AI-assisted work
AI-assisted work
Iterative collaboration throughout the workflow
Context, judgment and responsibility
- Regulatory interpretation
- Evidence appraisal
- Strategic decisions
- Accountability
Defensible regulatory outcomeStrategy · documentation · evidence · lifecycle compliance
Review of AI-generated regulatory documentation ↗Why MDRC
The decisions behind the documents matter
Compliance is created by consistent decisions about the product, its evidence, risks and lifecycle—not by document generation alone.
About MDRC ↗Specialist focus
Medical software, AI, connected technologies and IVD systems are our core field.
Connected expertise
Regulatory, software, clinical, risk and quality questions are handled as one system.
Direct responsibility
Senior expert judgment remains embedded from strategy through assessment.
Regulatory intelligence
Practical routes into complex requirements
Focused tools and guidance for understanding what the next regulatory step requires.
Start with the product
Bring us the technology, the regulatory question or the documentation gap.
We will help define the pathway and the work needed to move forward.
Discuss your product or regulatory pathway ↗
