Our Services
Comprehensive regulatory, quality, and development services designed to accelerate your medical device's path to market.
Our expert team provides end-to-end support across the entire product life cycle, from initial concept through regulatory submissions, post-market surveillance, and ongoing compliance. Whether you're developing software-based medical devices, connected healthcare technologies, or combination products, we provide the strategic guidance needed to achieve regulatory approval and commercial success.
Regulatory Affairs
Navigate FDA, EU MDR, and global regulatory pathways with confidence. We handle 510(k), De Novo, PMA, and CE marking submissions, develop pre-submission strategies, and build comprehensive global regulatory plans tailored to your device classification and target markets.
Quality Systems
Build and maintain robust quality management systems compliant with ISO 13485 and FDA QMSR. From design controls and CAPA procedures to supplier management and management review, we help establish the quality infrastructure your organization needs.
Product Development
End-to-end product development support from concept through commercialization. We guide design verification and validation, user-centered design per IEC 62366, risk management per ISO 14971, and manufacturing scale-up with full regulatory integration.
Medical Device Software
Specialized expertise in Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD). We support IEC 62304 life cycle implementation, risk categorization, algorithm validation, and pre-market submissions for software-driven medical technologies.
Cybersecurity
Comprehensive cybersecurity services aligned with FDA guidance. We perform threat modeling (STRIDE), CVSS risk assessments, SBOM generation, and develop secure product development frameworks including pre-market documentation and post-market vulnerability management.
Post-Market Surveillance
Develop and maintain post-market surveillance programs compliant with FDA and EU MDR requirements. We handle PMS plan development, adverse event management, vigilance reporting, PMCF study design, and real-world evidence generation.