European Union · Risk Management (ISO 14971 / MDR)
Risk Management File — ISO 14971 / MDR-aligned
Sobel leads and structures an ISO 14971 / MDR-aligned Risk Management File together with your team: we run discovery, expand hazards, build risk tables, write draft residual-risk narratives, create the GSPR mapping, and set a PMS-linked maintenance plan—using your device knowledge, policies, and judgments. Final content decisions and approval remain with the Legal Manufacturer.
ISO 14971 & MDR-aligned RMF (co-developed)
Expanded hazard coverage & risk tables
Residual-risk & benefit–risk draft narratives
GSPR mapping (Annex I)
Why Establishment Registration & Device Listing Matter
If you manufacture, develop, relabel, or import medical devices in the U.S., registration and listing are not optional—they are required under 21 CFR Part 807 and must be kept current.
- Mandatory obligations: U.S. device establishments must register with FDA and list their devices; this applies to manufacturers, specification developers, contract manufacturers, repackers/relabelers, and U.S.-based initial importers.
- Deadlines apply: Initial establishment registration and device listing must be completed within 30 days of starting regulated device activities.
- Annual user fee: Each year, between Oct 1 and Dec 31, establishments must review/update registration and listings and pay the FDA establishment registration user fee. Registration cannot be completed until FDA receives and processes this fee.
- Online system: All registration and listing activities are managed through FURLS and the Device Registration & Listing Module (DRLM).
- Not an approval: Being registered or listed does not mean FDA has approved or cleared your devices; it only reflects that your establishment and devices are in FDA’s databases.
A structured RMF framework built with your experts that Notified Bodies and auditors can follow.
What You Will Receive
Updated Risk Management File (RMF)
- Identification of which entities in your structure must register as establishments.
- Clarification of which devices must be listed and under which establishment.
- Timeline and responsibilities for initial registration/listing (30-day requirement) and annual Oct–Dec review.
GSPR mapping matrix
- Identification of which entities in your structure must register as establishments.
- Clarification of which devices must be listed and under which establishment.
- Timeline and responsibilities for initial registration/listing (30-day requirement) and annual Oct–Dec review.
Interfaces pack
- Identification of which entities in your structure must register as establishments.
- Clarification of which devices must be listed and under which establishment.
- Timeline and responsibilities for initial registration/listing (30-day requirement) and annual Oct–Dec review.
Maintenance mini-plan
- Identification of which entities in your structure must register as establishments.
- Clarification of which devices must be listed and under which establishment.
- Timeline and responsibilities for initial registration/listing (30-day requirement) and annual Oct–Dec review.
Change log & approvals note
- Identification of which entities in your structure must register as establishments.
- Clarification of which devices must be listed and under which establishment.
- Timeline and responsibilities for initial registration/listing (30-day requirement) and annual Oct–Dec review.
Scope: Consulting and documentation only. We do not act as a notified body, importer, or legal counsel. We cannot create a complete RMF in isolation—we rely on your device knowledge, policies, and evidence. The Legal Manufacturer reviews, supplements where needed, and signs the RMF.
Why Teams Choose Sobel for Independent ISO 10993-1 Gap Reviews
Sobel acts as a critical, precise external reader for your biological evaluation documentation—focusing on how reviewers interpret your files, not on selling generic tools.
- Independent perspective on how your dossiers align with the ISO 10993-1:2025 biological effects view and ISO 14971-style risk estimation.
- Tight focus on one outcome: a concise, prioritized gap report—not templates, scorecards, or ready-made drafts.
- Strong emphasis on how chemistry (ISO 10993-18) and toxicological risk assessment (TRA, ISO 10993-17:2023) support sufficiency judgments.
- Clear explanations of where rationales are robust, weak, or missing, written in reviewer-oriented language.
- Experience across multiple markets (EU, FDA, Brazil and others), reflecting how authorities frame ISO 10993-1 within the broader risk-management process.
How we work
We move from a clear inventory of your activities and products to a repeatable registration and listing routine.
Discovery & scope
- Facilitate focused discovery workshops and evidence intake with your subject-matter experts: confirm intended purpose, device variants, existing RMF content, supporting evidence sets (V&V, clinical, biocomp, usability), and PMS signals that only your team can provide.
Expand hazards & structure risk tables
- Together with your experts, expand hazard coverage and foreseeable misuse, then structure risk estimation and evaluation tables in line with ISO 14971 and MDR expectations, reflecting your acceptance criteria and risk policies.
Define controls & write narratives
- Work with your team to define and verify risk controls (design, process, information for safety), then draft residual-risk and overall benefit–risk narratives that your internal stakeholders review and refine before approval.
Map GSPRs & interfaces
- Build a concise GSPR mapping matrix (Annex I) using your existing documentation, and document interfaces between the RMF, CER, BER/TRA, usability, IFU/label, and PMS so traceability is clear and reflects your actual file set.
Maintenance & handover
- Package the updated RMF structure with a change log and a practical review cadence tied to PMS, agree triggers and owners with your team, and hand over a maintainable file set for you to operate and update.
What We Need From You
We rely on you for facts about your business and devices; we provide structure and guidance.
- Intended purpose, device description, and variants/configurations as defined by your team.
- Existing RMF (if any) and underlying evidence: verification and validation reports, clinical evaluation, biocompatibility, usability, software, etc.
- PMS signals you collect: complaints, vigilance cases, trend reports, and other post-market data.
- Your current acceptance criteria or risk policies (if any) to guide evaluation and decision-making.
- IFU and label extracts that you use to communicate risks and residual risks to users.
- Access to relevant internal experts (e.g., clinical, engineering, quality) to confirm scenarios, controls, and rationales.
Consulting and documentation for risk management only. We cannot create a complete RMF in isolation; we rely on your experts, evidence, and policies. We do not act as a notified body, importer, or legal counsel. The Legal Manufacturer remains responsible for final decisions, RMF approval, and all formal submissions and communications with authorities and Notified Bodies.
FREQUENTLY ASKED QUESTIONS
No. We provide the structure, drafting support, and regulatory alignment, but the RMF relies on your device knowledge, internal policies, and evidence. Your team must participate in workshops, supply documentation, and make the risk decisions that we then document.
No. We provide consulting and documentation services only. We help structure and write the RMF and related mappings; the Legal Manufacturer retains responsibility for decisions, approvals, and all formal submissions and communications.
We align the RMF with MDR risk management expectations and ISO 14971. Where applicable, we consider EN ISO 14971:2019 + A11:2021 for harmonized alignment and ISO/TR 24971:2020 for practical lifecycle guidance, always adapted to your device and evidence.
No. We work from the verification, validation, clinical, biocompatibility, usability, and PMS data you provide. We can highlight where additional testing or analysis may be justified, but you decide and commission any new studies.
Using your documentation and PMS processes, we build a GSPR mapping matrix that links Annex I requirements to risks, controls, and evidence, and we issue a maintenance mini-plan so RMF updates are triggered by your PMS outputs and other lifecycle changes.
No. This service is specifically for U.S.-based establishments. Concepts like a “U.S. Agent” are relevant for foreign establishments, not for U.S. companies.
Short Glossary
- Owner/Operator (O/O): The legal entity account used to access FURLS and manage registration and listing information.
- FURLS (FDA Unified Registration and Listing System): FDA’s online account system for registration and listing.
- DRLM (Device Registration & Listing Module): The FURLS module used specifically for medical device establishment registration and device listing.
- Initial registration & listing: The first registration and listing for a device establishment, required within 30 days of starting device activities.
- Annual review (Oct–Dec): The required yearly period to verify and update registration and listings and pay the establishment registration user fee.
- Not approval: A reminder that registration and listing do not equal FDA approval or clearance.
Build my Risk Management File
We’ll reply with a proposed slot and a short intake checklist so we can confirm your current RMF status, available evidence, and who from your team should join the workshops.
Contact Us
We would love to speak with you.
Feel free to reach out using the below details.
