Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
Medical device manufacturers must manage post-market reporting requirements across multiple jurisdictions, each with its own timelines, formats, documentation expectations, and regulatory obligations. Critical data is often spread across quality, regulatory, clinical, complaint-handling, and product teams, making it difficult to maintain visibility and consistency.
AlvaMed helps manufacturers centralize post-market information, organize reporting schedules, track jurisdiction-specific requirements, and prepare required reports through a streamlined process. This reduces internal workload, improves consistency, and gives teams a clearer view of global reporting obligations.
Structure innovation submission form.
Collect consistent information from the innovators for each innovation.
Source information is organized in a centralized repository to support efficient access, reuse, traceability, and consistency across reports.
AlvaMed identifies applicable reporting requirements, tracks region-specific timelines, and maintains a reporting calendar across relevant markets.
AlvaMed prepares and reviews reports using structured, AI-enabled workflows supported by regulatory, quality, and clinical professionals. Reports may include CERs, PSURs, PMCF Reports, regional annual safety reports, and other jurisdiction-specific documentation.
AlvaMed prepares and reviews reports using structured, AI-enabled workflows supported by regulatory, quality, and clinical professionals. Reports may include CERs, PSURs, PMCF Reports, regional annual safety reports, and other jurisdiction-specific documentation.
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
AlvaMed can support Clinical Evaluation Reports, Periodic Safety Update Reports, Post-Market Clinical Follow-up Reports, regional annual safety reports, and other jurisdiction-specific post-market reports. The exact reporting requirements depend on the device, classification, market, and applicable regulations.
Yes. AlvaMed can help identify jurisdiction-specific requirements, maintain reporting calendars, track deadlines, and organize reporting activities across multiple markets.
AlvaMed organizes relevant complaint, clinical, product, safety, risk, and post-market information in a centralized repository. This creates a consistent source of data that can be used across reports and jurisdictions.
AlvaMed uses AI-enabled workflows to support data organization, evidence summarization, report drafting, and consistency checks. All outputs are reviewed by experienced regulatory, quality, and clinical professionals before they are provided to the client.
No. AlvaMed prepares and reviews report drafts, but the manufacturer remains responsible for final approval and any required regulatory submission. AlvaMed can also provide submission support when requested.
This service is well suited for small and midsize medical device manufacturers managing post-market reporting across multiple jurisdictions without the internal resources to maintain separate reporting processes for every market.
Mark Cox leads AlvaMed’s Global Regulatory Reporting Services, bringing decades of experience in regulatory strategy, quality systems, and clinical affairs for medical device companies. He has helped organizations develop practical, scalable approaches to global compliance while integrating AI-enabled workflows that improve reporting efficiency, consistency, and quality. Mark works closely with clients to simplify complex reporting obligations and support regulatory compliance throughout the product lifecycle.
