FDA And ISO Regulations for Medical Devices in USA
Navigating Regulatory Complexities, Accelerating Medical Medical Innovation
We specialize in helping medical device companies confidently bring their innovations to market. With deep expertise in global regulatory pathways and quality management systems, we provide tailored consulting services that simplify complexity and accelerate compliance. Whether you’re launching a new product, expanding into new markets, or optimizing your quality systems, our goal is to be your trusted advisor at every step. From regulatory strategy and submissions to ISO 13485 implementation and audit readiness, we ensure you’re always inspection-ready and market-prepared. Let us help you turn regulatory challenges into strategic opportunities—so you can focus on what you do best: improving lives through innovation.
We work With regulatory bodies throughout the world
U.S. FDA (Food and Drug Administration) – 510(k), De Novo, IDE, PMA, & more
EU MDR & MDD – Technical Documentation, DoC, GSPR, ERC, & more
Health Canada
Japan PMDA (Pharmaceuticals and Medical Device Agency)
China NMPA (National Medical Products Administration)
Other Global Agencies (TGA, ANVISA, CDSCO, & more)
Regulatory Strategy Development
Regulatory strategy is the roadmap that guides your medical device from concept to commercialization. It ensures you’re on the most efficient path to market, fully aligned with the regulatory expectations of agencies like the FDA (U.S.), the European Medicines Agency (EU MDR), Health Canada, ANVISA, and others.
Regulatory Submission Development
We are committed to guiding you through the regulatory submission process whether it be 510(k), De Novo, IDE, PMA, Q-Submissions, Pre-submissions, Technical Documentation, Electronic Common Technical Document (eCTD), STEDs, and more. Our dedicated team of experts works closely with regulatory agencies worldwide to ensure your submissions are precise, compliant, and timely
Submission Pathway Assessment:
We identify the most appropriate submission route based on your device class, intended use, and target market (e.g., FDA 510(k), De Novo, PMA, EU MDR Technical File, CDSCO Form MD applications, etc.).
Gap Analysis and Readiness Review
We evaluate your existing documentation and product data to identify and close gaps before submission, reducing the risk of rejection or delays.
Submission Document Preparation
From creating complete FDA eSTAR files or MDR-compliant Technical Documentation to preparing Indian Device Dossiers (Form MD-7, MD-14, etc.), we ensure your submissions are technically sound and regulator-ready.
Scientific and Regulatory Writing
We draft key content such as: Executive Summaries, Risk Management Report, Labeling and IFU reviews, Regulatory Declarations and GSPR checklists.
Submission Management and Communication
We handle communications with regulatory agencies and notified bodies, respond to queries (AI letters, deficiency letters), and support during audits or reviews.
Post-Submission Support
From follow-ups and clarifications to planning for changes and resubmissions, we stay with you until your approval / clearnece is in hand—and beyond.
We prepare and manage 510(k) submissions to demonstrate substantial equivalence to legally marketed devices. Our services cover strategy, data gap analysis, document preparation, eSTAR formatting, and FDA interaction — helping you achieve efficient clearance and market entry.
We help you develop and maintain fully compliant Technical Documentation to support regulatory submissions and market access. Our experts prepare complete technical files and design dossiers aligned with EU MDR, FDA, and global regulatory requirements, covering device description, risk management, clinical and performance data, labeling, and post-market surveillance. Whether building files for new devices or remediating legacy documentation, we ensure your submissions meet the latest standards and withstand regulatory scrutiny.
For novel devices with no suitable predicate, we develop De Novo submissions to obtain a new device classification. We help with pre-submission strategy, evidence generation, and preparation of comprehensive documentation to establish a new regulatory pathway for your innovation.
Electronic Common Technical Document (eCTD)
We support the preparation and submission of eCTD-compliant dossiers for FDA and global regulatory authorities. Our services include document formatting, publishing, lifecycle management, and submission through regulatory gateways—ensuring your regulatory files are submission-ready and compliant with evolving electronic standards.
Summary Technical Documentation (STED)
We develop and optimize Summary Technical Documentation (STED) to support global market approvals in compliance with IMDRF and ISO 13485 guidelines. Our team prepares well-structured STED files that present essential device information clearly and effectively for regulators—facilitating streamlined reviews and global registration success.
We support IDE submissions to enable clinical studies of investigational medical devices in the U.S. Our services include regulatory strategy, study design input, preparation of IDE applications, and support for FDA interactions — helping you start clinical trials quickly and compliantly.
We guide you through the complex PMA process for Class III medical devices. Our team supports clinical strategy, scientific documentation, and FDA communication to ensure a high-quality submission package that meets FDA’s rigorous expectations for safety and effectiveness.
We help you strategically leverage FDA Q-Submissions (Pre-Subs) to gain valuable early feedback on your device development, regulatory strategy, clinical study design, and testing protocols. Our services include authoring Q-Sub packages, coordinating with FDA, preparing your team for productive meetings, and managing follow-up — helping you reduce risk and streamline your path to market.
Quality Management Systems (QMS) Development & Implementation
A robust QMS is essential for maintaining compliance and driving continuous improvement. We help medical device companies design, implement, and optimize Quality Management Systems (QMS) that comply with global regulatory standards, including ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and the Medical Device Single Audit Program (MDSAP) requirements. Whether you’re building a QMS from the ground up or enhancing an existing system, our team develops tailored quality processes aligned with your product type, business size, and market strategy—helping you achieve compliance across multiple jurisdictions with a single, harmonized system.
Our services include QMS gap assessments, SOP development, MDSAP readiness preparation, internal and supplier auditing, risk management integration, CAPA system design, document control, and audit support. We also guide your team through MDSAP audit preparation and help streamline your quality processes to drive continuous improvement and operational excellence—ensuring both regulatory compliance and sustained product quality.
Support with Regulatory Compliance & Quality System Audits
Navigating the complex web of global regulatory and quality system requirements can be daunting. We provide support to our clients during FDA, Notified Bodies, or any other regulatory agency audits.
Post Market Compliance
We help medical device companies build robust Post-Market Surveillance (PMS) and vigilance systems to meet evolving global regulatory requirements. Our services include developing PMS plans, Post-Market Clinical Follow-up (PMCF) plans and reports, Periodic Safety Update Reports (PSUR), and trend reporting. We support you in managing adverse event reporting, field safety corrective actions, and continuous risk-benefit evaluation—ensuring compliance with EU MDR, FDA, MDSAP, and other market expectations while driving ongoing product safety and performance.
Labelling and Ad-Promo
We ensure your labeling, Instructions for Use (IFU), and promotional materials align with applicable regulatory requirements and industry best practices. Our team provides labeling reviews for global markets (EU, US, Canada, APAC), supports UDI compliance, and evaluates advertising and promotional content for consistency with device claims and regulatory approvals—helping you minimize compliance risk while maintaining effective and compliant marketing communications.
Software as a Medical Device (SaMD) & Digital Health Compliance
We provide specialized regulatory support for software-based medical devices, including SaMD and connected health technologies. Our services address requirements from FDA guidance, EU MDR Annexes, and IMDRF principles—ensuring your digital products meet global standards
Regulatory Intelligence
We provide Regulatory Intelligence services to help medical device companies stay ahead of evolving global requirements and market trends. Our team continuously monitors regulatory changes, guidance updates, standards revisions, and competitor landscapes across key markets (FDA, EU MDR/IVDR, MDSAP countries, APAC, LATAM, and more). We translate this intelligence into actionable insights—informing your product development, regulatory strategy, and lifecycle planning. With proactive regulatory awareness, you can anticipate changes, reduce compliance risk, and accelerate informed decision-making for global market success.
Environmental & Sustainability Compliance
We support regulatory compliance with environmental directives such as RoHS, REACH, and WEEE—helping you meet sustainability expectations while maintaining product safety and performance.
Contact Us Today
Custom strategies. Faster approvals. Fewer roadblocks.