Tell us about your device, submission needs, and timeline.
Preparing an FDA submission takes a coordinated effort. Your intended use, testing, clinical evidence, quality processes, and technical documentation need to tell a consistent story.
RQMIS brings these disciplines together to help you identify gaps early, plan the work ahead, and prepare a clear, defensible submission.
One coordinated approach. The right expertise for your device, development stage, and submission.
Find Your Starting Point
Each submission serves a different purpose. We help determine the appropriate approach and connect your regulatory strategy with the evidence needed to support it.
Seek FDA feedback before key decisions.
RQMIS helps develop focused questions, prepare the submission package, support FDA meetings, and turn feedback into practical next steps. Topics can include testing, clinical study design, software, cybersecurity, and regulatory strategy.
A Pre-Submission provides FDA feedback; it does not authorize marketing.
Build the case for substantial equivalence.
For devices with an appropriate legally marketed predicate, RQMIS supports pathway and predicate assessment, evidence review, submission preparation, labeling alignment, and responses to FDA questions.
Plan a pathway for novel technology.
For eligible devices of low to moderate risk without a legally marketed predicate, RQMIS helps develop the regulatory rationale and organize risk, performance, and clinical evidence to support a De Novo classification request.
Prepare for investigational device studies.
RQMIS assists with Investigational Device Exemption applications and supplements, investigational plans, study documentation, and regulatory coordination.
Significant-risk device studies require FDA and Institutional Review Board approval before beginning.
Bring the scientific evidence together.
For devices requiring Premarket Approval, RQMIS supports application preparation, integration of clinical and nonclinical evidence, FDA interactions, and supplements. The goal is a submission that supports reasonable assurance of safety and effectiveness for the intended use.
The expertise behind your submission
Choose targeted assistance or coordinate multiple services within one project. The scope is tailored to your device, available documentation, and development needs.
Pathway assessment, gap analysis, technical writing, evidence integration, labeling and claims review, and FDA communication. If a submission encounters deficiencies, we help identify the underlying issues and prepare responses and revised documentation.
Study objectives, endpoints, protocols, statistical considerations, site selection, IRB submissions, startup, monitoring, and study management. Support extends through data management, safety reporting, analysis coordination, closeout, and clinical study reports.
QMS design, implementation, and improvement aligned with FDA QMSR and ISO 13485. We support design controls, risk management, document control, training processes, supplier and manufacturing quality, and corrective and preventive action.
Translate user needs and intended use into design specifications. RQMIS supports prototype refinement, usability considerations, and verification and validation activities that connect product development with submission evidence.
For software-enabled devices and Software as a Medical Device, we provide software development and validation/testing support, helping align software activities and documentation with quality and regulatory needs.
Threat modeling, risk assessments, secure architecture reviews, SBOM planning, vulnerability management, and submission documentation. Our services and partnerships also support penetration testing, attack simulation, remediation, postmarket planning, continuous monitoring, and incident response.
Internal audits, compliance assessments, inspection preparation, and remediation help strengthen your quality foundation. RQMIS also assists with FDA Form 483 responses, warning letters, and related compliance issues.
Small Business Determination applications, establishment registration and device listing, U.S. Agent and FDA Official Correspondent services, labeling review, GUDID submissions, and Medical Device Master Files. Export certificate assistance is available where applicable.
Complaint handling, adverse event reporting, health hazard assessments, recalls, trend analysis, risk updates, and postmarket clinical follow-up. Reimbursement strategy, initial importer, EU Authorized Representative, and UK Responsible Person services can support broader market plans.
Customized training and temporary regulatory, clinical, and quality support help address project demands. We can also help develop team structures, responsibilities, and workflows as your organization grows.
Your next step
Whether you are preparing for your first FDA interaction, planning a clinical study, building a marketing submission, or responding to FDA questions, RQMIS can help define the work ahead and provide the expertise to carry it forward.
Tell us about your device, submission needs, and timeline.