Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
ISO 14155:2026: What Medical Device Teams Need to Know
August 31, 2026
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.
AlvaMed works with you to identify reporting requirements and deadlines across relevant markets and establish a coordinated reporting calendar for your products.
AlvaMed establishes a repeatable approach to accessing and collecting information from your existing systems and data owners, tailored to your organization’s processes and security requirements.
AlvaMed’s regulatory, quality, and clinical professionals prepare draft reports for your review. Reports may include CERs, PSURs, PMCF reports, PMA annual reports, and other jurisdiction-specific reporting.
AlvaMed delivers drafts according to an agreed schedule that allows time for your team’s review before reporting deadlines. We incorporate your feedback and prepare final reports for your approval.
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 works with your team to identify relevant information sources and establish a repeatable process for accessing complaint, clinical, product, safety, risk, and other post-market data. The approach is tailored to your existing systems, data owners, and security requirements, reducing the effort your team spends gathering information for each reporting cycle.
Yes. AlvaMed uses AI tools to support routine activities such as organizing information and preparing draft content. Experienced regulatory, quality, and clinical professionals review all outputs before they are shared with your team.
No. AlvaMed prepares and reviews draft reports so your team can focus on key findings and conclusions before final approval. Your team retains responsibility for approving the reports and completing any required regulatory submission, with submission support available from AlvaMed upon request.
This service is well suited for small and midsize medical device manufacturers seeking to reduce the time their teams spend managing recurring post-market reports. Support can be tailored to a single product and report or a portfolio spanning multiple markets, allowing internal staff to focus on key findings, conclusions, and final approval.
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 works with clients to establish practical reporting processes tailored to their products, markets, and internal resources. His approach combines experienced professional review with efficient data collection and report preparation, helping client teams focus on key findings, conclusions, and regulatory decisions.
