FREQUENTLY ASKED QUESTIONS
Medical Device Consulting FAQ
Answers to the questions manufacturers most often ask about FDA submissions, EU MDR, quality systems, and bringing a medical device to market. Have a question that isn't here? Contact our regulatory team.
What does a medical device consultant do?
A medical device consultant helps manufacturers bring devices to market and keep them compliant. This includes regulatory strategy, preparing FDA and EU submissions, building and remediating quality management systems (ISO 13485 / FDA QMSR), risk management (ISO 14971), design controls and Design History Files, and audit and inspection support. Sequence Group provides all of these services across US and global markets.
What is an FDA 510(k) submission and how long does clearance take?
A 510(k) is a premarket submission demonstrating that a device is substantially equivalent to a legally marketed predicate device. The FDA targets a 90-day review, though the total timeline depends on the device, the quality of the submission, and any Additional Information requests. A well-prepared submission that passes the FDA Refuse to Accept (RTA) screening is the most reliable way to avoid delays.
What is the difference between a 510(k), a De Novo, and a PMA?
A 510(k) is used when a valid predicate device exists (low-to-moderate risk). A De Novo is used for novel low-to-moderate risk devices that have no predicate, and it establishes a new device type and classification. A PMA (Premarket Approval) is the most rigorous pathway, required for high-risk Class III devices and supported by clinical evidence. Choosing the correct pathway early is one of the highest-leverage regulatory decisions, and Sequence Group develops that strategy with you.
Do foreign medical device manufacturers need a US Agent to sell in the United States?
Yes. The FDA requires every foreign establishment that imports devices into the US to designate a US Agent who acts as a communication liaison with the FDA. Sequence Group provides FDA-designated US Agent services, handling establishment registration, device listing, and all FDA correspondence on the manufacturer’s behalf.
What is the FDA QMSR and how is it different from the old Quality System Regulation?
The Quality Management System Regulation (QMSR) became effective on February 2, 2026, replacing the legacy Quality System Regulation at 21 CFR Part 820. The QMSR incorporates ISO 13485:2016 by reference while retaining FDA-specific requirements such as complaint files and MDR reporting. Manufacturers already certified to ISO 13485:2016 have a shorter path to compliance, but still need to document the linkage to the FDA-specific supplementary requirements.
What is required for EU MDR compliance and CE marking?
EU MDR 2017/745 requires a compliant technical documentation file, a Clinical Evaluation Report based on the specific device, an ISO 13485 quality system, post-market surveillance and (by device class) PSUR/PMSR reporting, UDI assignment, EUDAMED registration with a Single Registration Number, and notified-body involvement for most device classes. Sequence Group helps manufacturers build MDR-ready technical files and plan their conformity assessment route.
What is ISO 13485 and does my company need it?
ISO 13485:2016 is the international standard for medical device quality management systems. Certification is required or strongly preferred for market access in the EU, Canada, Australia, Japan, and many other markets, and it now forms the technical backbone of the FDA QMSR. Most device manufacturers need an ISO 13485 quality system; Sequence Group designs, implements, and remediates these systems for single- and multi-market compliance.
What is a Design History File (DHF) and why does it matter?
A Design History File documents that a device was developed according to its design plan and design controls — capturing user needs, design inputs and outputs, verification and validation, design reviews, and traceability. A complete, well-structured DHF is essential for FDA submissions and inspections. Sequence Group optimizes and remediates DHFs to ensure they withstand regulatory scrutiny.
Does my connected medical device need cybersecurity documentation?
If your device contains software and has any network or internet connectivity, it almost certainly qualifies as a “cyber device” under Section 524B of the FD&C Act. Premarket submissions must then include a Software Bill of Materials (SBOM), a cybersecurity management plan, threat modeling, and evidence of a secure product development framework. Sequence Group integrates these requirements into your design controls and submission.
Can AI/ML-based devices be updated without a new FDA submission?
Yes — through a Predetermined Change Control Plan (PCCP). A PCCP, submitted as part of a 510(k), De Novo, or PMA, describes in advance the algorithm modifications you plan to make and the protocol that will govern them, allowing approved changes without a new marketing submission. Sequence Group structures PCCPs that balance regulatory specificity with practical flexibility for iterative AI/ML development.
How much does medical device regulatory consulting cost?
Cost depends on the scope — a focused regulatory strategy or gap assessment is far less than a full 510(k) submission or a complete quality system build. Sequence Group scopes each engagement to the device, pathway, and timeline, and offers a free initial consultation to define the work before any commitment.
Still have questions?
Get a free consultation with our regulatory experts.