Nilo Medical Consulting Group
Consulting and CRO services for medical device, pharmaceutical, and biotech companies, focused on regulatory strategy and submissions, clinical trial design and execution, quality systems and product lifecycle support, post-market surveillance, and regulatory-ready data practices. Supports clients from early concept through global market entry.
Industries
Nr. of Employees
small (1-50)
Nilo Medical Consulting Group
Pittsburgh, Pennsylvania, United States, North America
Services
Strategic regulatory planning and preparation of submission packages for U.S. and global pathways, agency interactions, and designation requests.
Protocol development, site management, monitoring, data management, safety oversight, and study reporting as full-service clinical research support.
QMS development and audit readiness aligned to 21 CFR 820 and ISO 13485, risk management, and inspection support.
Support for design controls, verification & validation planning, usability/human factors, and regulatory-aligned product development across lifecycle stages.
Regulatory and clinical writing services plus reimbursement strategy development to align evidence with payer expectations.
Strategic regulatory planning and preparation of submission packages for U.S. and global pathways, agency interactions, and designation requests.
Protocol development, site management, monitoring, data management, safety oversight, and study reporting as full-service clinical research support.
QMS development and audit readiness aligned to 21 CFR 820 and ISO 13485, risk management, and inspection support.
Support for design controls, verification & validation planning, usability/human factors, and regulatory-aligned product development across lifecycle stages.
Regulatory and clinical writing services plus reimbursement strategy development to align evidence with payer expectations.
Expertise Areas
- Regulatory strategy and submissions
- Clinical trial management and CRO services
- Quality management systems (21 CFR 820, ISO 13485)
- Post-market surveillance and real-world evidence
Key Technologies
- Electronic Data Capture (EDC) systems
- Real-World Evidence (RWE) from EHRs and registries
- Software Bill of Materials (SBOM) and software component tracking
- Threat modeling and device cybersecurity controls
News & Updates
Panel presentation on early-stage company building, fundraising, and scaling at LSI USA 2026 (panel includes company president).
Virtual AMA session on regulatory trends including QMSR, AI/ML & SaMD, and compliance strategies presented by company leadership.
Networking mixer and strategy session timed with RAPS Convergence 2025 focused on regulatory affairs and medtech strategy.
Panel on generating investor-ready clinical data via strategic site partnerships at LSI Europe '25.
Overview of FDA expectations for device cybersecurity, including threat modeling, SBOMs, mitigation controls, and postmarket management.
Guidance on EU MDR technical documentation, CERs, GSPR checklists, PMS/PMCF, and Notified Body engagement for EU market entry.
Panel presentation on early-stage company building, fundraising, and scaling at LSI USA 2026 (panel includes company president).
Virtual AMA session on regulatory trends including QMSR, AI/ML & SaMD, and compliance strategies presented by company leadership.
Networking mixer and strategy session timed with RAPS Convergence 2025 focused on regulatory affairs and medtech strategy.
Panel on generating investor-ready clinical data via strategic site partnerships at LSI Europe '25.
Overview of FDA expectations for device cybersecurity, including threat modeling, SBOMs, mitigation controls, and postmarket management.
Guidance on EU MDR technical documentation, CERs, GSPR checklists, PMS/PMCF, and Notified Body engagement for EU market entry.