FDA And ISO Regulations for Medical Devices in USA
Navigating Regulatory Complexities, Accelerating Medical Medical Innovation
At Omnee Strategic Solutions, 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 Devices Agency)
China NMPA (National Medical Products Administration)
Other Global Agencies (TGA, ANVISA, CDSCO, & more)
Our Expertise
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
What is Regulatory Submission Development
Regulatory submission development is the process of compiling and organizing all the technical, clinical, and administrative documentation required by regulatory bodies to approve or clear a medical device. Each market has unique formats, requirements, and expectations—getting it right the first time is key.
Our Approach
We bring deep regulatory know-how and a strategic mindset to help you navigate the submission process with confidence and efficiency. Our services include:
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.
Why It Matters
Our clients trust us to transform complex regulatory expectations into clear, actionable, and high-quality submissions that move products forward—fast.
Regulatory Strategy Development
Crafting a comprehensive regulatory strategy is the cornerstone of success in the medical device industry. Our experts work closely with you to develop a roadmap that ensures compliance while maximizing efficiency and minimizing time to market. We partner with your team to build a custom regulatory strategy that fits your device, your timeline, and your target markets
What is 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), CDSCO (India), and others.
Our process includes
Product Classification: We assess your device and determine its regulatory class in each market, which dictates the approval process and evidence required.
Global Market Planning: Whether you’re launching in the U.S., EU, India, or multiple geographies, we map out the appropriate regulatory pathways (e.g., 510(k), CE Marking, De Novo, PMA, or CDSCO licensing).
Evidence and Testing Strategy: From biocompatibility and electrical safety to clinical evaluations and human factors testing—we help you define what’s needed and when.
Labeling and Claims Review: We ensure your intended use and marketing claims are both compelling and compliant, minimizing risk during submission reviews.
Timeline and Milestone Planning: With deep knowledge of regulatory timelines, we help you build realistic plans to meet product launch goals—without surprises.
Change Management and Lifecycle Support: Regulatory strategy doesn’t end at approval. We help you manage post-market changes, new indications, and regulatory updates smoothly.
We bring deep regulatory know-how and a strategic mindset to help you navigate the submission process with confidence and efficiency. Our services include:
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.
Why It Matters
A strong regulatory strategy reduces time to market, avoids costly rework, and builds trust with investors and regulators alike. It’s your foundation for global growth—and we’re here to help you build it right.
Post Market Compliance
Compliance doesn't end with product launch. Our post-market support services ensure ongoing adherence to regulatory requirements, including adverse event reporting, post-market surveillance, corrective and preventive actions (CAPA), and recalls. We help you stay ahead of these challenges with a proactive, structured, and compliant approach.
What is Post Market Compliance?
Once a medical device is on the market, manufacturers are required to monitor its performance, manage risks, and stay compliant with evolving regulatory expectations. Regulatory bodies demand rigorous post-market surveillance—and failing to comply can lead to product recalls, fines, or loss of certification.
Our Post-Market Compliance Services
From setting up robust surveillance systems to managing field actions, we offer end-to-end support tailored to your product and markets.
Post-Market Surveillance (PMS) Plans & Reports:
We develop and maintain EU MDR-compliant PMS Plans and Periodic Safety Update Reports (PSUR), tailored by device risk class and usage.
Complaint Handling Systems:
We help you design, implement, and optimize complaint handling processes that meet FDA 21 CFR 820.198, EU MDR, and ISO 13485 standards.
Vigilance and Adverse Event Reporting:
We support timely and accurate reporting of adverse events and Field Safety Corrective Actions (FSCAs) to the relevant authorities (e.g., FDA’s MDR, EU NCAs, CDSCO Form MD-15).
Post-Market Clinical Follow-up (PMCF):
We help you design and execute PMCF plans and studies to continuously collect and evaluate clinical data, in line with EU MDR Annex XIV.
CAPA and Risk Management Integration:
We ensure post-market signals feed directly into your CAPA system and ISO 14971-based risk management process, maintaining a closed-loop quality system.
Surveillance Audit Readiness:
We prepare you for relgulatory body audits, FDA inspections, and CDSCO reviews with document gap assessments, mock audits, and SOP alignment.
Why It Matters
Whether you’re a startup launching your first device or a global company scaling across markets, we help you build a resilient post-market strategy that protects your brand—and your patients.
Stay compliant with evolving global regulations
Build trust with regulators, users, and partners
- Reduce risk of field actions and loss of market access
- Keep quality and safety at the center of your growth
Labelling and Ad-Promo
Creating and reviewing product labels, manuals, marketing literature, and other documentations to ensure they meet regulatory requirements. We help you develop, review, and optimize your materials to ensure they’re clear, accurate, and regulator-ready.
Why Labelling and Ad-Promo Matters
Medical device labelling and promotional content must meet strict regulatory requirements in every market where you operate. Inaccurate or misleading claims, improper use instructions, or noncompliant promotional language can lead to regulatory warnings, delays in approval, or even product recalls.
Whether you’re preparing for a submission, launching a new product, or scaling to new markets—getting your messaging right is critical.
Our Labelling & Ad-Promo Services
Labeling Compliance Review: We assess your product labels, Instructions for Use (IFU), packaging artwork, and UDI information to ensure they meet regional standards (e.g., FDA 21 CFR Part 801, EU MDR Annex I, CDSCO GSR 102(E)).
Global Labelling Strategy: We help you harmonize labelling content across jurisdictions, considering differences in: language requirements, regulatory statements, intended use and indications, symbol usage (per ISO 15223-1)
Promotional Content Review: We review your marketing materials—brochures, websites, videos, digital campaigns, trade show content—for regulatory compliance. We ensure: no off-label claims, balanced risk/benefit presentation, appropriate use of testimonials, visuals, and comparison
Advertising and Promotional Material SOPs
We help you build internal processes for compliant promotional review and approval—essential for avoiding risk in high-growth phases.
Label Creation & Editing
Need support with content development? We draft and edit: Labels and cartons, Instructions for Use (IFUs), Promotional copy aligned with regulatory submissions.
Audit and Enforcement Readiness
We help you stay inspection-ready with clear documentation, change control systems, and compliant archiving practices.
Quality Management Systems (QMS) Development & Implementation
A robust QMS is essential for maintaining compliance and driving continuous improvement. We provide comprehensive support in implementing QMS frameworks tailored to your organization's unique needs, ensuring adherence to ISO 13485, MDSAP, and other relevant standards.
Why QMS Matters
A Quality Management System isn’t just about ticking boxes—it’s about embedding quality into every stage of your product lifecycle. Regulatory bodies require an established and functioning QMS aligned with standards like ISO 13485, 21 CFR Part 820, and country-specific regulations.
A well-designed QMS:
- Speeds up market entry
- Reduces nonconformities and product issues.
- Enhances operational efficiency and team alignment
Builds a foundation for global scalability
Our Approach
Whether you’re building from scratch, upgrading to meet MDR, or transitioning from ISO 9001, we tailor QMS solutions to fit your business model, product complexity, and market goals.
QMS Planning & Strategy: We assess your business, device class, and target markets to develop a right-sized QMS roadmap aligned with your regulatory and operational needs.
Full QMS Development (ISO 13485 & 21 CFR Part 820): We help you design and implement all required processes and documentation:
- Quality Manual
- SOPs and Work Instructions
- Forms, Templates, Records
- Quality Policy & Objectives
QMS Gap Assessment & Remediation: Already have a QMS? We identify gaps against ISO 13485:2016, FDA QSR, or EU MDR requirements—and help you close them efficiently.
Electronic QMS (eQMS) Setup & Optimization: We support implementation and configuration of eQMS tools, tailored to your processes and audit needs.
Internal Audit Program Development: We build audit programs, train your team, and perform mock audits to ensure ongoing compliance and audit readiness.
QMS Training & Change Management: From onboarding new teams to scaling global operations, we ensure your staff understands and follows QMS processes through practical, role-based training.
Regulatory Audit & Inspection Readiness: We prepare you for FDA inspections, Notified Body audits, and more—with documentation reviews, walkthroughs, and audit simulations.
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.
Why QMS Matters
Whether you’re preparing for:
- A routine surveillance audit
- Pre-market FDA or CDSCO inspection
- ISO 13485 certification
- MDSAP certification
- A notified body’s unannounced audit
…your preparedness directly impacts your regulatory standing, business continuity, and market credibility.
Our audit support ensures:
- Your systems are compliant and current
- Your documentation is complete and traceable
- Your team is trained and confident under pressure
Our Audit Support Services
Internal Audit Execution & Program Development: We perform independent, risk-based internal audits across QMS processes, ensuring alignment with ISO 13485, 21 CFR Part 820, MDR, and MDSAP requirements.
Mock Regulatory Audits & Inspection Simulations: Simulate real audit conditions with our mock audits—designed to uncover gaps, prepare your teams, and practice clear, compliant responses.
Gap Assessments & Corrective Action Planning: We identify nonconformities or documentation gaps and help implement practical, sustainable corrective and preventive actions (CAPAs).
Audit Response Support & Remediation: Need help responding to 483s, nonconformance, or audit findings? We guide your team through root cause analysis, CAPA development, and response drafting.
Document Control & Evidence Compilation: We help organize, review, and align your records—including DHF, DMR, CAPA logs, SOPs, training files, complaint records, and PMS documentation.
Team Training for Audit Preparedness: We provide customized training for your staff on audit behavior, document handling, and inspection readiness—including how to answer questions under pressure.
Remote & Hybrid Audit Readiness: We help you prepare for virtual audits by organizing digital files, securing remote access, and facilitating smooth auditor interactions.
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
What is SaMD
Software as a Medical Device (SaMD) refers to software intended to be used for medical purposes—without being part of a physical device. This includes:
- Diagnostic algorithms
- Digital therapeutics
- Remote monitoring tools
- AI/ML-based clinical decision support
- Mobile health apps and platforms
SaMD is regulated differently across regions (e.g., FDA, EU MDR, CDSCO), requiring a specialized compliance approach.
Our SaMD & Digital Health Services
We support the full lifecycle—from strategy and classification to regulatory submissions and post-market oversight.
Global Regulatory Strategy for SaMD: We help you determine device classification, intended use, and the right regulatory pathway across markets:
- FDA (e.g., 510(k), De Novo, enforcement discretion)
- EU MDR/IVDR under MDCG guidance for SaMD
- India’s CDSCO registration and voluntary pathways
Cybersecurity & Data Privacy Compliance: We help you meet growing expectations around cybersecurity (FDA premarket guidance, MDR Annex I) and ensure alignment with privacy laws (HIPAA, GDPR).
Software Lifecycle Documentation (IEC 62304): We assist with:
- Software Development Lifecycle (SDLC) documentation
- Risk management per ISO 14971
- Usability (IEC 62366)
- Verification & Validation plans and reports
AI/ML-Specific Regulatory Guidance: For adaptive algorithms and AI models, we help you align with emerging FDA and EU frameworks for transparency, explainability, and performance monitoring.
Labeling & Promotional Review for Digital Tools: We ensure your marketing claims are supported by evidence and stay within the regulatory limits—especially important in the digital health space.
Post-Market Surveillance & Vigilance for SaMD:
We support complaint handling, performance monitoring, and adverse event reporting processes designed specifically for software products.
Risk Management & ISO 14971 Compliance
We help you develop and maintain risk management files in line with ISO 14971 and integrate them into your quality system. Our approach is proactive, product-specific, and audit-ready.
What is ISO 14971?
ISO 14971 is the internationally recognized standard for applying risk management to medical devices, including Software as a Medical Device (SaMD). It requires manufacturers to identify, evaluate, control, and monitor risks throughout the entire product lifecycle—from design to post-market use.
Global regulators including the FDA, EU MDR, and CDSCO mandate compliance with ISO 14971, making it a cornerstone of your quality and regulatory framework.
Our Risk Management Services
We provide comprehensive support in building, integrating, and maintaining risk management systems.
Risk Management Plan Development: We help define your risk policy, responsibilities, scope, and acceptance criteria—customized for your product class and complexity.
Hazard Identification & Risk Analysis
Using methods like FMEA, FTA, and hazard analysis, we help you systematically identify potential risks across:
- User interactions
- Software failure
- Electrical safety
- Biocompatibility
- Data integrity and cybersecurity (especially for SaMD)
Risk Control Strategy Design: We guide you through risk reduction techniques (inherent safety, protective measures, information for safety) and help you justify residual risks.
Risk-Benefit Analysis & Evaluation: We ensure your documentation demonstrates acceptable benefit-risk profiles—essential for CE Marking, FDA 510(k)/PMA, or CDSCO licensing.
Risk Management File (RMF) Compilation: We help compile complete, audit-ready RMFs, fully traceable to your Design History File (DHF) and Technical Documentation.
Integration with ISO 13485 & QMS: We align your risk processes with your Quality Management System for seamless cross-functional compliance, including feedback from CAPA, complaints, and PMS.
Training & Team Enablement: We offer practical training for R&D, RA/QA, and clinical teams on applying ISO 14971 in day-to-day product development and reviews.
Regulatory Intelligence
Monitoring and interpreting changes in regulations and guidelines that mat affect company's products and/or operations..
What is Regulatory Intelligence
Regulatory Intelligence is the process of continuously gathering, analyzing, and interpreting data on regulations, guidelines, and standards that affect medical devices, digital health solutions, and combination products. It’s about staying informed on policy changes, emerging trends, and market entry requirements globally.
Having up-to-date regulatory intelligence allows you to:
- Avoid compliance risks
- Accelerate market access
- Navigate complex global regulations with confidence
Our Regulatory Intelligence Services
We provide tailored, proactive, and actionable intelligence that empowers your team to stay ahead of regulatory developments, make informed decisions, and streamline market entry.
Global Regulatory Updates & Monitoring: We track changes across regions, including updates to FDA, EU MDR, CDSCO, and other regional regulations, so you don’t miss key changes that could impact your strategy.
Regulatory Strategy Adjustments: Our team interprets regulatory changes and helps adjust your product development and market entry strategies to align with new requirements and avoid delays.
Policy Analysis & Impact Assessments: We analyze new and proposed regulations, ensuring your team understands the implications for your products, including potential market barriers, testing requirements, and approval timelines.
Standards and Guidance Monitoring: We keep you informed about updates to medical device standards like ISO 13485, ISO 14971, IEC 62304, and more—helping you maintain ongoing compliance with industry best practices.
Competitive Intelligence & Benchmarking: We provide insights into competitor strategies, regulatory filings, and trends, giving you a competitive edge in the global market.
Risk & Opportunity Identification: We help you identify both risks and opportunities in the regulatory landscape, allowing you to pivot quickly and seize new market opportunities.
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.
Why Environmental Compliance Matters
Environmental regulations are becoming increasingly stringent worldwide, affecting how devices are designed, sourced, packaged, and disposed of. Regulatory bodies now expect manufacturers to demonstrate environmental responsibility at every stage.
Key compliance areas include:
- RoHS (Restriction of Hazardous Substances)
- REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals)
- WEEE (Waste Electrical and Electronic Equipment)
- Packaging Waste & Labeling
- Battery Directive
- ESG Reporting Requirements
Failure to comply can lead to product recalls, loss of market access, reputational damage, and legal liability.
Our Services in Environmental & Sustainability Compliance
RoHS & REACH Compliance Support
We help you assess and ensure that your device components meet hazardous substance and chemical use regulations for EU and global markets.
WEEE, Battery, and Packaging Directive Compliance: We assist in meeting end-of-life recycling, labeling, and take-back obligations, especially for electrical devices and battery-powered products.
Contact Us Today
We understand the intricate web of regulations governing the medical device industry. We provide comprehensive regulatory and quality consulting services to ensure your product meets the highest standards of compliance while driving innovation forward.