Technology before templates
We begin with the actual product architecture, clinical function, users and development environment.
About MDRC
Regulatory expertise built around medical technology
MDRC connects regulatory, clinical, quality and software-lifecycle expertise to help medical technology companies make coherent, defensible product and compliance decisions.
MDRCExpert regulatory
judgment
judgment
Technologysoftware · AI · devices
Clinical purposeusers · claims · benefit
Evidencesafety · performance
Qualityprocesses · records
Lifecyclerelease · change · PMS
Different disciplines · one regulatory direction
Why MDRC exists
Complex products need connected regulatory thinking
Medical software, AI-enabled healthcare technologies and connected devices do not fit within one professional discipline. Their regulation depends on how technology, clinical purpose, risks, evidence, quality processes and market requirements work together.
MDRC was built around that connection. We help companies establish one product story and carry it consistently through development, evidence, documentation and market access.
TechnologyClinicalRiskQualityEvidence
Expert interpretationrequirements · context · responsibility
Connected outcomeOne defensible regulatory pathwayEU MDR · IVDR · FDA
How we think
The principles behind our work
Good regulatory work is not measured by the number of documents generated. It is measured by whether the decisions behind those documents are coherent, supported and able to withstand assessment.
Judgment before document production
We translate requirements into product-specific decisions and take responsibility for the reasoning behind them.
Evidence as one system
We align intended purpose, risks, requirements, testing, clinical evidence and technical documentation.
Compliance across the lifecycle
We plan for releases, modifications, incidents and post-market evidence rather than treating approval as the end point.
Combined expertise
One team perspective across the regulatory system
Our work combines the disciplines needed to move a software-centered medical product from early definition to market access and controlled post-market change.
EU and US pathways
MDR, IVDR, FDA strategy, qualification, classification, conformity assessment and regulatory interaction.
Software and connected systems
IEC 62304, architecture, requirements, verification, validation, interoperability and controlled releases.
Evidence and human use
Clinical or performance evaluation, claims, usability, benefit-risk and meaningful product performance.
Risk, security and quality
ISO 14971, cybersecurity, ISO 13485, technical documentation and post-market surveillance.
How we work with companies
An extension of your product and regulatory team
We work alongside founders, product leaders, engineers, clinicians and quality teams. Engagement can begin with an early concept, a product in development or an existing compliance system that needs a clearer direction.
The objective is not to create a parallel regulatory process. It is to integrate regulatory requirements into the way the product is defined, developed, evidenced and changed.
- 01
Understand the product
Technology, intended purpose, users, clinical role and development status.
- 02
Define the direction
Product boundary, classification, market pathway and evidence expectations.
- 03
Build the system
Development records, risks, evidence, documentation and quality processes.
- 04
Support decisions and change
Assessment, submissions, regulatory interaction, updates and post-market obligations.
Our focus
Built for companies developing software-centered medical technologies
MDRCRegulatory and technical expertise
Medical software companies
AI healthcare innovators
Digital health platforms
Software-driven device manufacturers
Work with MDRC
Your technology needs one coherent regulatory direction
Whether you are defining a new medical product, preparing for market access or restructuring an existing compliance system, MDRC helps connect the technology, evidence and regulatory decisions behind it.
Discuss your product with MDRC
