Services

Comprehensive QA/RA Solutions Tailored for Medical Device Innovation

Why Regulatory Frontier

Most medical device startups lose 12–18 months navigating regulatory hurdles they didn’t see coming. We exist to change that.

Regulatory Frontier delivers end-to-end regulatory and quality assurance expertise built specifically for medical device innovators — from first prototype to global market scale.

Our approach goes beyond filing paperwork. We embed regulatory thinking into every stage of your product journey — from standards mapping and QMS setup to country-specific submissions and post-market compliance. This means fewer surprises, faster clearances, and a compliance foundation strong enough to impress even the toughest auditors and investors.

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10+ Regulatory Submissions Cleared

19 Global Markets Served

17 Medical Devices Approved

90% First-Attempt Success Rate

Your Regulatory Journey — Stage by Stage

From first idea to global market leader, we stand with you at every critical regulatory milestone so you move faster, safer, and with confidence.

Pre-Seed / Idea Idea & Concept “Lay the compliance foundation before you write a single line of code or draw a single design.” Identify device-specific compliance requirements — applicable standards (IEC 60601-1, ISO 13485, ISO 14971, etc.) Map applicable clauses within each standard — e.g., IEC 60601-1 Clause 8.4 (Creepage & Clearance distances): one of the most critical & consistently missed requirements at prototyping — failing to account for correct electrical separation distances leads to expensive PCB redesigns post-testing Regulatory pathway assessment — FDA 510(k) / PMA, CE marking (EU MDR), CDSCO, TGA, and more Country-specific device classification & intended use definition 💰 ₹15,000 – 20,000 / month	1
	2	Seed Stage Development “Build your device right the first time — with quality baked in, not bolted on.” Quality Management System (QMS) implementation from the ground up (ISO 13485 aligned) Developing SOPs, Formats & Records tailored to your specific device and processes Streamlining critical processes — production process & purchase/procurement process Component-specific regulatory requirements guidance for your team Supplier qualification guidance — ensuring critical suppliers are compliant so you don’t face Non-Conformances (NCs) during audits or regulatory submissions 💰 ₹18,000 – 25,000 / month
Seed / Pre-Series A Premises Finalisation “Your facility is part of your regulatory submission — design it right from the start.” Floor map finalization — layout planning that meets regulatory requirements Cleanroom requirements identification, ISO 14644 classification, setup & compliance specific to your device type ESD (Electrostatic Discharge) lab design, setup & compliance Environmental monitoring planning & documentation Facility compliance documentation preparation for regulatory submissions 💰 ₹15,000 – 22,000 / month	3
	4	Series A Testing Phase “Don’t just test your device — build the evidence package that regulators demand.” Lab finalization — identifying & shortlisting NABL/accredited labs certified for your specific device testing requirements Budget-conscious lab selection strategy to maximize value Test planning & protocol development — generating sufficient evidence to prove device performance Support during testing to ensure data integrity, traceability & documentation quality Gap analysis between test results and regulatory evidence requirements 💰 ₹20,000 – 30,000 / month
Series A / B Pre-Submission “Navigate every country’s regulatory maze with a guide who has been there before.” Country-specific regulatory submissions — FDA (USA), CE Mark (EU MDR), CDSCO (India), TGA (Australia), ANVISA (Brazil), PMDA (Japan) & more Local liaison & authorized representative coordination in each target country Application filing & clearance tracking throughout the review process Clinical study support & Clinical Evaluation Report (CER) preparation Risk Management File (ISO 14971) tailored to each submission’s requirements Validation documentation — IQ/OQ/PQ, software validation — specific to target country requirements 💰 ₹25,000 – 35,000 / month	5
	6	Series B / C Growth & Scale “Expand into developed markets at speed — where the real revenue lives, even though the path is tough.” Ongoing regulatory query management — answering questions from each country’s regulatory authority so you scale at pace Multi-country regulatory strategy for simultaneous or sequential market entries Supporting investor reporting with regulatory milestones & compliance status to demonstrate returns Regulatory intelligence — monitoring changes in standards and regulations across all active markets Converting regulatory compliance into a competitive advantage in premium developed markets 💰 ₹20,000 – 28,000 / month
Post-IPO / Mature Post-Market Compliance “Stay compliant, stay trusted — protect your brand and your market access forever.” Post-Market Surveillance (PMS) system setup & execution Proactive complaint handling & adverse event reporting (MDR / vigilance reporting) Periodic Safety Update Reports (PSUR) & Post-Market Clinical Follow-up (PMCF) Trend analysis & proactive data collection to prevent recalls or permanent bans CAPA (Corrective & Preventive Action) management to protect regulatory standing globally 💰 ₹15,000 – 20,000 / month	7

Expertise in Specific Regulations

OUR SERVICE PORTFOLIO

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We would love to learn more about your medical device project and discuss how we can work together.

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At Regulatory Frontier, we don’t just file paperwork — we become your dedicated compliance partner from day one. Whether you’re drawing your first sketch or preparing for a Series C fundraise, we give you the regulatory clarity to move fast, impress investors, and reach patients in markets that matter.

Every stage of your journey is covered — and because we work month-to-month, you stay agile without locking in capital. No retainers you don’t use. No surprises you can’t afford.

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