AlvaMed, Inc.

AlvaMed, Inc. provides regulatory affairs, quality management, and clinical operations consulting services exclusively to medical device companies. The firm specializes in helping medtech organizations navigate FDA and international regulatory pathways, establish compliant quality systems, and execute clinical studies for both pre-market and post-market requirements.

The company offers comprehensive support across the product development lifecycle, from initial device classification and regulatory strategy through FDA submissions, QMS implementation, and ongoing compliance management. Their services include FDA 510(k) submissions, EU MDR clinical evaluation reports, MDSAP mock audits, design history file remediation, and full-service clinical study management. AlvaMed employs a template-driven approach to quality system setup and design control documentation, enabling clients to maintain systems independently after initial implementation.

The firm reports that 90% of their business comes from repeat clients, with 100% of clients rating them as excellent in deliverable quality and value received. Their leadership team brings decades of hands-on medical device industry experience across regulatory affairs, quality assurance, and clinical research.

Organizations should consider AlvaMed when they need medical device regulatory and quality expertise but lack internal bandwidth or specialized knowledge for FDA submissions, QMS establishment, or clinical study execution. The firm's template-based methodologies provide structure while building client capability for long-term independence.

Companies facing regulatory inspection findings, managing device portfolio transitions, or integrating acquired product lines will find relevant remediation and harmonization experience. The high rate of repeat engagements suggests clients value the consultative approach and return for additional projects as their product portfolios expand.

AlvaMed operates exclusively in the medical device sector, providing specialized consulting across the regulatory, quality, and clinical functions required for device approval and commercialization. The firm's expertise spans FDA regulatory pathways (510(k), De Novo, IDE, HDE), EU MDR compliance, ISO 13485 quality systems, and 21 CFR Part 820 requirements.

Their healthcare specialization extends to clinical study design and execution for medical devices, including CRO services, site management, and preparation of clinical evaluation reports for both US and European submissions. The team addresses device-specific compliance challenges including design controls, risk management files, supplier auditing, and CAPA program management tailored to medtech manufacturing environments.

Medical device companies at any stage from pre-market development through commercial operations who need regulatory affairs, quality system, or clinical study support. Particularly well-matched for organizations building their first QMS, preparing initial FDA submissions, addressing inspection findings, or harmonizing quality systems following acquisitions. Companies value their willingness to provide client references and consultative approach to complex regulatory challenges.