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Accelerating 510(k) and EU MDR Submissions for an Orthopedic Device Trial Across 3 Regions

A U.S.based medtech company developed a novel orthopedic implant designed to support foot and ankle joint stabilization in patients with degenerative conditions and post-traumatic injuries. Preparing for FDA 510(k) clearance and CE marking, the client needed a partner to conduct a pivotal device safety and performance trial across multiple orthopedic centers.

Client Challenges

  • Execute a prospective, multicenter clinical investigation in compliance with ISO 14155 and FDA IDE requirements
  • Recruit patients with specific foot and ankle pathologies requiring surgical intervention
  • Coordinate between orthopedic surgeons, radiologists, and rehabilitation teams
  • Collect high-quality radiographic, functional, and safety data for regulatory submission
  • Meet tight timelines for submission to FDA and notified bodies for dual-market launch

Clinvigilant Research Solution

Clinical Strategy & Regulatory Road mapping

Designed and refined the clinical investigation plan (CIP) with clear primary and secondary endpoints, including:

  • Device integration and stability (radiographic evaluation)
  • Postoperative pain and mobility (VAS, FAAM scores)
  • Incidence of device- or procedure-related adverse events
  • Navigated dual compliance pathways: FDA IDE (21 CFR Part 812) and EU MDR 2017/745 clinical evidence requirements
  • Supported IRB approvals, DMC setup, and risk mitigation plans

Monitoring, Safety & Reporting

  • Used risk-based monitoring to track protocol compliance and AE reporting
  • Coordinated with sponsor and DSMB for safety alerts and interim analyses
  • Produced clinical study report (CSR) and clinical evaluation report (CER) aligned with EU MDR Annex XIV

Site Management & Investigator Engagement

  • Activated 5 top-tier orthopedic surgery sites across the U.S., India and EU
  • Delivered specialized training for surgeons and study coordinators
  • Deployed Clinvigilant's Surgical CRF Toolkit, enabling standardized data capture for:
  • Operative notes
  • Implant tracking
  • Rehab milestones
  • Imaging schedules

eClinical Technology

  • Enabled secure capture of x-ray and MRI evaluations at baseline, post-op, and follow-up
  • Captured PROMs (e.g., Foot and Ankle Ability Measure) via ePRO on tablet at clinics

Outcomes

78 across 5 sites

Total Participants Enrolled

98%

Follow-Up Completion Rate

1 event

(non-serious, resolved)

Device-Related
AE Rate

91.7% of patients showed full implant fusion

Radiographic Success

Filed 4 weeks
after DB lock

FDA 510(k) Submission

Completed and accepted by
NB within 6 weeks

EU MDR CER Submission

Client Testimonial

Chief Clinical Officer
Orthopedic Device Company
Clinvigilant helped us bridge orthopedic science, imaging, and regulatory rigor. Their device trial expertise was vital for both FDA and MDR pathways.

Value Delivered

By blending clinical operations, orthopedic specialization, and regulatory knowledge,
Clinvigilant Research enabled this medtech innovator to generate high-integrity clinical data – leading to a fast, successful submission and a strong foundation for post-market entry in two major regions.

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