Navigating FDA compliance can be overwhelming—especially with shifting requirements and tight timelines. Isaac Erickson works with teams who don’t have in-house regulatory experts, helping them avoid submission errors, reduce delays, and stay on track. Whether you’re unsure if your device qualifies for a 510(k), or struggling to understand eSTAR, Isaac provides the clarity and support needed to move forward with confidence.
Isaac specializes in preparing high-quality eSTAR applications for Class I, II, and III devices, aligning each submission with FDA expectations to streamline the review process. From identifying the right pathway to minimizing the risk of AIQs, he helps reduce uncertainty, accelerate approvals, and protect your product launch timeline.
Labeling mistakes can lead to costly delays, recalls, or even enforcement action. Many teams struggle with FDA requirements, UDI barcode formatting, and international translation rules, especially when managing multiple markets. Issac helps companies close these gaps with a comprehensive, audit-ready review that aligns with FDA, EU MDR, and ISO standards.
Whether you need UDI implementation, a full labeling compliance check, or support with global labeling strategy, Isaac provides hands-on guidance to reduce risk and keep your product moving forward.
UDI requirements are complex and easy to get wrong. Many companies struggle with selecting the right issuing agency, formatting barcodes, submitting to the GUDID, or managing UDI data across global databases. These issues can delay approvals, trigger enforcement actions, or create long-term compliance risks.
Isaac helps companies implement and manage UDI systems that meet FDA 21 CFR Part 830 and align with international standards like EU MDR and EUDAMED. From barcode strategy to data validation and submission, Isaac streamlines every step, reducing errors, improving traceability, and keeping your device launch on track.
Expanding into international markets brings regulatory challenges that many teams aren’t prepared for. Requirements vary widely across countries, and missing key steps like selecting a local representative, aligning technical files, or translating labels can stall approvals. Many companies underestimate the complexity of foreign product registrations until it’s too late.
Isaac helps medical device companies navigate these systems with clarity and precision. With experience in Latin American regulations, like Mexico, Peru, and Colombia, and a deep understanding of global compliance frameworks, he can guide you through registration, documentation, and post-market obligations so you can enter new markets without delays or costly setbacks.
Work With an Experienced 510k Submission Consultant
Isaac Erickson has helped medical device companies successfully navigate 510(k), De Novo, and PMA pathways. Isaac’s process is built to reduce friction, improve submission quality, and get your device to market faster. Whether you’re building your first 510(k) or need to recover from a stalled application, Isaac offers the support and strategy you need to get it right the first time.