Move from uncertainty to approval with a submission-first plan. We help teams define claims, select the right pathways, build audit-ready documentation, and communicate effectively with Notified Bodies and FDA—covering Medical Devices including SaMD.
EU & US coverage • Calm audits • Reviewer-ready files
Intended use/indications, target markets, and route to market. Clear acceptance criteria and timelines.
EU MDR/IVDR classification and US FDA class/product codes based on risk, claims, and technology.
Compare current QMS & evidence to MDR Annex II/III and/or FDA submission expectations.
Hazard analysis, benefit-risk, usability and cybersecurity woven into claims and documentation.
Right-sized files mapped to reviewer checkpoints (SaMD & hardware).
Prepare, submit, and respond—efficiently and on time.
Clinical operations/PMCF and eQMS platform work are coordinated with vetted partners when needed.
We align software life-cycle evidence with claims and risk to avoid “nice-to-have” artifacts.
| Deliverable | Purpose | Typical outputs |
|---|---|---|
| Regulatory strategy & plan | Define route to market, timelines, owners | Claims map, pathway decision, submission schedule |
| Classification memo | Document EU/FDA class & rationale | EU rules & FDA product codes with justification |
| Gap analysis | Identify remediation to meet MDR/IVDR or FDA | Annex II/III & 510(k) checklists, prioritized actions |
| Risk & safety package | Demonstrate risk control & usability | ISO 14971 file, IEC 62366-1, cybersecurity plan |
| SaMD dossier (if applicable) | Software life-cycle evidence | IEC 62304 docs, SOUP list, verification reports |
| Technical Documentation / 510(k) | Submission-ready files | TD index or 510(k) sections with cross-references |
| Agency interaction log | Track questions & responses | NB/FDA correspondence & commitments register |
Clinical/PMCF execution and eQMS implementation delivered with partners when required.
Eligible micro/small enterprises can appoint CENIT as the named PRRC with EU presence and defined availability.
Foreign establishments can designate CENIT as U.S. Agent to handle FDA communications and inspection scheduling.
We ensure seamless integration of these roles with your submission plan and QMS.
Yes. We regularly handle standalone software, connected systems, and traditional devices, aligning evidence to claims and risk.
Great—we’ll map it to MDR/IVDR or QMSR, identify only the gaps, and keep changes lean.
Yes. We coordinate with your preferred partners or bring vetted partners for PMCF, clinical ops, and eQMS.
Discovery can begin within days. After a short scoping call, we provide a dated plan with owners and deliverables.
Yes. We treat shared information as confidential and can use your NDA template or ours.
Book a free consultation. We’ll confirm class, outline your pathway, and share a practical deliverables plan.
Contact us to find out more about Regulatory Affairs