Quality & Regulatory
FDA & CE Compliance
Compliance without Compromise
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.
QMS Design
& Support
Systems that Scale with You
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
Making Quality a Habit
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.
Gap Analysis &
Submission Readiness
Compliance Starts Here
Regulatory clarity is mission-critical. Our team conducts in-depth gap analyses to uncover compliance risks across your quality systems, technical documentation, and regulatory files. We align your development efforts with FDA, EU MDR, and other global requirements so there are no surprises at submission. Whether you're preparing for 510(k), CE marking, or beyond, we help you move forward with confidence.
Post-Market Surveillance & Compliance
Compliance doesn't Stop at Launch
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 and FDA requirements ensuring your product remains compliant and competitive after launch.
Deficiency Letters & Remediation Services
Compliance Back on Track
When regulatory agencies raise questions, your response needs to be fast, focused, and flawless. We help MedTech innovators and device developers tackle FDA and global regulatory deficiency letters with clarity and confidence. Our team brings deep technical fluency and regulatory insight to craft persuasive responses and remediation strategies that align with your product and goals. From pre-sub to post-market, we keep your innovation moving forward.
DHF Generation &
Technical Documentation
Technical Files that Align with Regulations
We support device developers and regulatory teams in generating Design History Files (DHF) and technical documentation that meet FDA, EU MDR, and other global regulatory expectations. Whether you're preparing for market clearance or navigating design controls, we ensure your documentation is accurate, complete, and submission-ready. Our team combines regulatory insight with technical precision to build audit-proof files that accelerate approvals. Let us handle the complexity so you can focus on product development.
Risk Management & Design Controls
Safer Products by Design
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.
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.