Regulatory & Compliance
Building innovative healthtech products means nothing without the right regulatory backbone. Through our regulatory partner D2R Global Consulting, we help startups and enterprises navigate the full spectrum of healthcare regulations, certifications, and compliance frameworks, ensuring your product is ready for both market and audit.
01
End-to-End Regulatory Documentation
We prepare all required documentation, including Technical Files, QMS procedures, and Validation Reports, aligned with standards like ISO 13485, IEC 62304, and MDR.
02
Compliance for AI & SaMD Products
Ensure your AI/ML and digital health software meet FDA, CDSCO, and EU MDR classification and regulatory expectations, from clinical validation to market clearance.
03
Certification & Audit Support
D2R Global Consulting brings over 8 years of regulatory experience with a team of 30 experts, having delivered 350+ projects and 125+ regulatory approvals across global markets.
04
Risk Management & Quality Systems
Implement structured ISO 14971 risk frameworks, CAPA systems, and internal audit programs that align engineering with quality and patient safety goals.
05
Regulatory Cloud & Market Readiness
Combine D2RGC’s compliance depth with MetaCXO’s cloud and DevOps expertise to deploy auditor-ready, compliant infrastructures for certifications like ISO 27001, HIPAA, and SOC 2.
Who We Work With:
Clinician Founders
HealthTech Startups
Academic Institutes
Medical Device Companies
Frequently asked questions
Together, we support certifications including ISO 13485, ISO 27001, HIPAA, IEC 62304, MDR, and CDSCO Class A–D device registrations, covering both software and hardware medical products.
Ideally from the very start. Early alignment with standards like ISO 13485 or HIPAA avoids redesign later. MetaCXO and D2RGC embed compliance into your development roadmap from concept to market.
Yes. D2RGC manages the entire certification process, from gap assessments and document preparation to liaison with notified bodies, regulatory authorities, and auditors.
The MetaCXO–D2RGC alliance combines deep technical execution with regulatory mastery - giving startups access to an integrated framework where product development, cloud setup, and certification progress together, not separately.