QMSR and ISO 13485 alignment
Gap assessment, priority setting, document and record review, process mapping, and implementation support for quality-system readiness.
Medical-device consulting
Quality and regulatory support built for scrutiny.
Independent, focused support for teams strengthening quality systems, closing compliance gaps, preparing for inspections, or bringing regulated products through demanding development milestones.
Where we can help
Medical-device work succeeds when regulatory requirements, quality-system controls, product evidence, and day-to-day operations tell the same story. Jiro Engineering helps teams identify where that story breaks—and turn the gaps into controlled work.
Service areas
Practical support across the quality lifecycle.
Exact activities and deliverables are defined by product, market, lifecycle stage, internal ownership, and engagement scope.
CAPA, nonconformance & remediation
Problem definition, containment, root-cause structure, action planning, effectiveness checks, and remediation-program coordination.
Audit and FDA inspection preparation
Readiness reviews, evidence mapping, mock interviews, document-retrieval practice, response planning, and execution support.
Design & development, risk management & technical records
Requirements and traceability review, ISO 14971 risk-management integration, verification and validation planning, and technical-record structure support.
Supplier-quality systems
Risk-based supplier controls, qualification and monitoring frameworks, quality-agreement inputs, and supplier corrective-action support.
Procedures, training & governance
Usable procedures, role clarity, training materials, management-review inputs, quality metrics, and escalation paths.
Regulatory research & market-entry planning
Regulatory landscape research, U.S., EU, and Swiss market-entry workplans, requirement mapping, decision briefs, and coordination points for authorized representatives, notified bodies, legal counsel, and other qualified specialists where applicable.
Quality and regulatory project planning
Workstreams, dependencies, owners, milestones, evidence expectations, review gates, and supplier or specialist coordination for defined quality and regulatory objectives.
Current U.S. context
FDA’s Quality Management System Regulation is now in effect.
The QMSR amended 21 CFR Part 820 and incorporates ISO 13485:2016 by reference. FDA stopped using QSIT on February 2, 2026 and now uses the inspection process in Compliance Program 7382.850. Readiness work should reflect the current regulation and inspection program.
Current regulatory frameworks
U.S., European Union, and Switzerland.
Market-entry and quality-system work is scoped against adopted requirements in the target market. Formal representation, conformity assessment, certification, and agency decisions remain with the responsible economic operators, authorities, and designated bodies.
FDA / CDRH
Current framework: 21 CFR Part 820 Quality Management System Regulation (QMSR), incorporating ISO 13485:2016 by reference. FDA device inspections now follow Compliance Program 7382.850 rather than QSIT.
FDA QMSRMDR / IVDR
Current framework: Regulation (EU) 2017/745 (MDR), consolidated through July 19, 2026, and Regulation (EU) 2017/746 (IVDR), together with applicable amendments, MDCG guidance, competent-authority, notified-body, and EUDAMED obligations. The current MDR consolidation incorporates Delegated Regulations (EU) 2026/1359 and (EU) 2026/1451. Since May 28, 2026, the Actor, UDI/Device, and Notified Bodies & Certificates modules are mandatory where the relevant actor or device obligations apply; the Market Surveillance module is mandatory for competent authorities and the European Commission.
Swissmedic / FOPH
Current framework: the Therapeutic Products Act (TPA), Medical Devices Ordinance (MedDO; SR 812.213), and In Vitro Diagnostic Medical Devices Ordinance (IvDO; SR 812.219). Swissmedic oversees medical-device market surveillance and relevant registration processes; FOPH prepares updates to the legislative framework on behalf of the FDHA. Market-entry planning can include Swiss authorized-representative obligations, CHRN actor registration, and swissdamed device-registration requirements.
Switzerland is assessed separately from the EU. Swiss requirements are closely aligned with EU medical-device rules in many areas, but economic-operator, registration, market-surveillance, and representation obligations must be checked under the Swiss framework.
Typical deliverables
Outputs designed to remain useful after handoff.
Deliverables are tailored to the engagement and integrated with the client’s approved systems and responsibilities.
Assessment package
Evidence-based findings, risk ranking, dependencies, owners, and a sequenced action plan.
Controlled documentation
Drafts or revisions structured for review, approval, implementation, and ongoing maintenance.
Readiness evidence map
A traceable view of applicable requirements, supporting records, known gaps, and retrieval ownership.
Remediation workplan
Milestones, resources, governance, decisions, quality gates, and effectiveness measures.
Training and facilitation
Targeted materials and sessions aligned to roles, process changes, and inspection behavior.
Executive decision brief
A concise view of exposure, options, recommended action, and what remains unresolved.
Fit
Designed for teams that need focused senior attention.
Jiro Engineering is best suited to defined problems where disciplined analysis and hands-on execution matter more than adding a large consulting team.
Established medical-device companies
Support for quality-system improvement, remediation, inspection preparation, or high-priority documentation work.
Scaling regulated-product teams
Help translating early practices into controlled systems that can support product, commercial, and regulatory growth.
International teams entering the U.S.
U.S.-focused quality and regulatory readiness support, coordinated with the client’s legal, regulatory, and authorized representatives.
Time-sensitive quality events
Structured support when findings, recurring failures, supplier issues, or deadlines require concentrated execution.
Frequently asked
Before an engagement begins.
Initial discussions are used to understand scope, urgency, available evidence, and whether Jiro Engineering is the right fit.
Does Jiro Engineering provide legal advice or guarantee regulatory outcomes?
No. Jiro Engineering provides quality, regulatory, and engineering consulting within a written scope. Legal advice, formal regulatory representation, certification, and agency decisions remain with appropriately qualified parties and the relevant authorities.
Can Jiro Engineering support a limited assessment before a larger project?
Yes. A bounded assessment is often the best first step when the problem, evidence, or likely remediation effort is not yet clear.
Can work be performed remotely?
Many documentation, assessment, planning, and advisory activities can be performed remotely. On-site support can be considered where the scope, location, and timing justify it.
How are confidential materials handled?
Confidentiality, access, approved systems, retention, and data-handling expectations are established before sensitive client information is exchanged.
Discuss the situation
Contact Jiro Engineering
Share the finding, deadline, or quality-system objective.
We will use the first conversation to determine fit, the information needed, and whether an assessment or defined work package is the right next step.