QARA is the combined medical device function that pairs Quality Assurance (QA) with Regulatory Affairs (RA). QA maintains the quality management system and confirms products meet requirements, while RA secures and sustains market authorization. Together they keep a device compliant, safe, and legally marketable across its lifecycle.
What is QARA?
QARA stands for Quality Assurance and Regulatory Affairs. In medical device companies, it usually names a single team—or a leadership role—that owns two linked responsibilities. Quality Assurance keeps the quality management system (QMS) running and verifies that design, medical device manufacturing, and supplier activities produce conforming devices. Regulatory Affairs interprets the rules that apply in each target market, builds the submissions needed for approval, and maintains that approval after launch.
The two disciplines are separate skills, but they draw on the same evidence. A design history file, a risk file, and a set of process validations serve QA during an audit and RA during a submission. Grouping them under QARA reflects how tightly QA and regulatory affairs depend on each other in a regulated product.
Why QARA matters in medical device development
A device cannot reach patients without both quality and regulatory clearance, so QARA sits on the critical path to market. Weak QA shows up as audit findings, nonconformities, and field actions. Weak RA shows up as rejected submissions, delayed launches, and lost market access. Either failure carries a direct cost.
The stakes are concrete. An FDA warning letter or a notified body nonconformity can halt shipments. A missed post-market reporting deadline can trigger enforcement. Because medical device timelines are long and capital-intensive, a regulatory slip late in a program is expensive to unwind. QARA exists to catch these problems early, while a design or process can still be changed cheaply.
How QARA works
QARA operates across the full medical device lifecycle rather than at a single approval gate. Its responsibilities begin during product planning and design, continue through regulatory submission and manufacturing, and extend into post-market monitoring and product sustenance. The core activities usually include:
- Quality management system. Building and maintaining a QMS to ISO 13485:2016, the standard now incorporated by reference into FDA 21 CFR Part 820 under the Quality Management System Regulation (QMSR), effective February 2, 2026.
- Risk management. Applying ISO 14971 across design and production so that hazards are identified, controlled, and monitored.
- Regulatory strategy and submissions. Classifying the device, selecting an appropriate pathway—such as a US 510(k) or CE Marking under EU MDR 2017/745—and assembling the required technical documentation.
- Design controls. Confirming that requirements are traceable, design verification and validation are complete, identified risks are controlled, and the required evidence is approved before design transfer.
- Post-market surveillance. Running complaint handling, adverse event reporting, and, in the EU, EUDAMED registration, mandatory for the first four modules since May 28, 2026.
Software devices add IEC 62304 for the software lifecycle and IEC 62366-1 for usability engineering. Each activity feeds a shared evidence base, so the same records support both an audit and a submission.
Common challenges and best practices
The most common mistake is treating QARA as a final checkpoint. Teams that bring QA and RA in only before submission often discover that design decisions made months earlier are not defensible, forcing rework. Bringing QARA into early design reviews avoids that.
A second problem is fragmented documentation. When risk files, design outputs, and validation records live in separate systems with no traceability, both audits and submissions become slow and error-prone. Good practice keeps these records linked from the start.
A third is treating regulatory requirements as static. Standards and rules shift: the QMSR changed how US quality requirements are cited, and EUDAMED obligations have moved from voluntary to mandatory. QARA teams need a process to track editions, effective dates, and jurisdiction-specific rules rather than assuming last year’s citation still holds. Strong teams also keep QA and RA talking to engineering continuously, not only at handoffs.
How SJML helps with QARA
SJML provides QARA as a service, allowing medical-device teams to access quality and regulatory expertise without building the entire function in-house. Its Compliance-as-a-Service offering spans regulatory strategy and device classification, international registration—including FDA 510(k), CE Marking under EU MDR, and IVDR pathways—technical documentation, clinical evaluation, and post-market surveillance. SJML also supports ISO 13485 quality systems, ISO 14971 risk files, and SaMD lifecycle activities under IEC 62304. Teams can scale this support as a program moves through design, submission, manufacturing, and product sustenance.
Frequently asked questions
QARA stands for Quality Assurance and Regulatory Affairs. In the medical device industry, the two functions are often combined into one team or role because they rely on the same underlying evidence. QA maintains the quality management system and product conformity, while RA secures and maintains the market authorizations that let a device be sold.
No. Quality Assurance is one half of QARA. QA focuses on the quality management system, process control, and product conformity. Regulatory Affairs, the other half, focuses on classification, submissions, and ongoing compliance with authorities such as the FDA and EU notified bodies. QARA is the combined discipline that manages both together across a device program.
Core standards and regulations include ISO 13485:2016 for the quality management system, ISO 14971 for risk management, and IEC 62304 for medical device software. In the US, 21 CFR Part 820 (now the QMSR) applies; in the EU, Regulation 2017/745 (MDR) governs market access. The exact set depends on device type and target markets.
From the start. Bringing QARA in during early concept and design work lets teams build compliant evidence as they go, rather than reconstructing it before a submission. Early involvement reduces rework, shortens approval timelines, and lowers the risk of design decisions that later prove hard to defend in an audit or regulatory review.
