We provide Compliance-as-a-Service to medical device OEMs, helping navigate global requirements with clarity. Our experts support the regulatory lifecycle – from classification and strategy to documentation, risk management, submission preparation, and post-market sustenance.
We partner with OEMs to meet ISO 13485, EU MDR, and FDA (21 CFR Part 820) requirements, ensuring device safety and performance. By aligning regulatory pathways with product development, we streamline approvals and enable faster market entry.
We support CDSCO regulatory approvals through manufacturing license applications, test license support, import registrations, technical documentation, and regulatory coordination for compliant market access.
Countries
Supported
Global Regulatory Submissions
Regulatory &
Technical Documents
Complaints
Managed
Quality &
Regulatory Audits
We offer services for sustained compliance via DHF remediation, ISO 13485/MDSAP QMS, ISO 14971 risk files, labelling & packaging, biocompatibility, supplier audits, EUDAMED.
We offer services for sustained compliance via DHF remediation, ISO 13485/MDSAP QMS, ISO 14971 risk files, labelling & packaging, biocompatibility, supplier audits, EUDAMED.
We manage complaints and vigilance through structured intake and investigation, adverse event reporting, root cause analysis with CAPA, and ongoing safety and vigilance reporting.
We enable global registration through device classification, regulatory pathway strategy, EU MDR/IVDR & CE marking, FDA 510(k) filings, technical files, and country-specific approvals.
We offer end-to-end clinical document development including CEP, CER, literature review, SSCP preparation, and clinical data management to support regulatory submissions and compliance.
We support PMS/PMCF through PMCF planning and execution, safety monitoring and vigilance reporting, PSUR/PMSR reporting, and field safety corrective actions (FSCA).
We enable software and digital health compliance through SaMD regulatory support, IEC 62304 lifecycle alignment, EU AI Act readiness, and cybersecurity risk assessment (IEC 81001-5-1).
We ensure PFAS and materials compliance through PFAS assessment and mitigation, RoHS, REACH & SVHC alignment, Prop 65 support, EPR reporting, and supply chain documentation.
We support M&A activities through regulatory and quality due diligence, integration-phase gap analysis and remediation, and standardization of QMS and documentation.
Our Quality & Regulatory Managed Services provide end-to-end QARA ownership through a structured, managed service model. With flexible, on-demand resource scaling and centralized governance backed by KPI tracking, we ensure consistent oversight and performance. From submissions and audits to post-market obligations, we support the entire regulatory lifecycle—enabling seamless compliance, operational efficiency, and sustained product continuity.
Developed a regulatory and clinical evidence pathway, integrating FDA 510(k) substantial equivalence justification with EU MDR-compliant CER restructuring, SOTA strategy, and evidence planning for Multi geographical submission support.
Regulatory, quality, and post-market compliance execution enabling faster multi-country approvals, stronger supplier governance, and scalable global expansion.
Regulatory strategy, documentation, and multi-country submissions executed to enable faster market access and scalable global expansion for an ophthalmic diagnostic device.
Engage experienced medical device quality assurance and regulatory affairs experts to accelerate approvals and sustain global market access over your entire device lifecycle.
Quality Assurance and Regulatory Affairs (QARA) encompass the systems and processes required to ensure medical devices are safe, effective, and compliant with applicable regulatory requirements throughout their lifecycle. Key aspects of QARA in the medical device industry include design controls, quality management system implementation, clinical and performance evaluation, risk and CAPA management, regulatory submissions, audits, labeling and packaging compliance, and post-market surveillance.
Medical device quality assurance (QA) focuses on establishing and maintaining compliant quality management systems (QMS), process validation, and supplier controls to ensure consistent product quality. Regulatory affairs (RA) refers to charting regulatory pathways, preparing for global submissions, securing approvals, and maintaining compliance with market-specific regulations. Together, QA and RA function as an integrated discipline to support compliant product development, manufacturing, commercialization, and post-market sustenance.
Yes. We provide international registrations support for major global markets, including FDA submissions and EU MDR requirements. Our teams help with device classification, pathway planning, technical file and DHF compilation, CE marking, FDA submissions, and coordination with regional authorities for timely market entry.
Our post-market compliance support includes PMS and PMCF planning, complaint handling and trend analysis, safety monitoring, PSUR and PMSR reporting, vigilance activities, and regulatory sustenance. We help organizations manage post-market obligations proactively, ensuring continued compliance as regulatory expectations and product usage evolve.
Absolutely. Our clients include established global OEMs, mid-size firms, as well as startups. We offer flexible engagement models to tailor QARA support to the maturity, scale, and complexity of each organization. For startups, we help develop compliant foundations early through device classification assessment, QMS implementation, risk management, and regulatory planning. Larger manufacturers typically engage us for regulatory sustenance, global registrations, audits, change management, and post-market compliance for their product portfolios.
Our QARA, engineering, and manufacturing teams operate under one roof, enabling close collaboration and streamlined execution. QARA works alongside engineering and manufacturing to embed compliance into design transfer, process validation, supplier assessment, documentation (DHF, DMR, DHR), and production controls. This integrated approach reduces rework, prevents compliance gaps during scale-up, and ensures continuous regulatory compliance throughout manufacturing operations.
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