FDA & CE Compliance
We guide clients through the full regulatory process, from pre-submission strategy to post-market support. Our team is experienced with 510(k), De Novo, PMA, and CE Mark pathways, ensuring your device meets the latest FDA and EU MDR requirements. We help you identify the appropriate regulatory strategy and build submission-ready documentation aligned with current expectations.
Quality & Regulatory
Regulatory Support
We act as an extension of your team, offering targeted regulatory expertise exactly when you need it. This includes classification and predicate analysis, regulatory strategy development, clinical evaluation planning, labeling reviews, and pre-submission meeting prep. We also support global registrations through partnerships and regional expertise.
Our team has an in-depth knowledge of preparing technical files to support submissions for 510(k), Letter to File, Clinical Decision Support Tools, De Novo products, and systems needing ISO 13485 compliance.
Quality System Generation
For startups and scaling companies, we design and implement custom-fit Quality Management Systems (QMS) compliant with ISO 13485, FDA 21 CFR Part 820, and EU MDR. We create SOPs, templates, and tools that are right-sized to your team and product complexity — helping you build a quality foundation that grows with your business.
Quality Assurance
Our Quality Assurance services ensure your processes, documentation, and deliverables meet internal standards and regulatory expectations. We support design controls, risk management, CAPA, change control, internal audits, and supplier quality management. Whether you're preparing for an audit or managing ongoing compliance, we keep quality at the forefront.
Risk Management & Design Controls
We integrate ISO 14971-compliant risk management and robust design control processes from the outset of development. Our team facilitates traceability, maintains DHF documentation, and supports structured reviews to ensure product safety and regulatory alignment throughout the design lifecycle.
Submission Readiness
We help prepare and package regulatory submissions, including 510(k)s, technical files, and Design Dossiers. We review and organize all necessary documentation — including testing results, labeling, risk analyses, and software validation — to streamline the review process and reduce back-and-forth with regulatory bodies.
Post-Market Surveillance & Compliance
Our team provides ongoing support for complaint handling, vigilance reporting, recalls, and periodic reviews. We help clients implement effective post-market surveillance programs that align with MDR, FDA, and MDSAP requirements — ensuring your product remains compliant and competitive after launch.