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EXPERTISE

One connected team for the hard parts of device development.

Qualira supports medical-device teams through strategy, submissions, clinical programs, quality systems, and the work that follows.

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01

Regulatory strategy development + reimbursement

A regulatory and reimbursement plan shaped around your product, intended use, evidence, and market goals.

  • Classification and pathway planning
  • Reimbursement planning
  • Regulatory pre-submissions
  • Global market planning
  • Evidence strategy
02

Regulatory submission preparation

Submission support from pre-submissions through product submissions, with the logic and documentation working together.

  • IDE
  • 510(k)
  • De Novo
  • 513(g)
  • PMA
  • CE Marking
  • Global device registration and licensing
03

Clinical strategy and trials

Clinical work designed to create decision-quality evidence while staying connected to the regulatory program.

  • Protocol development
  • EDC and database UAT
  • IRB submission materials
  • Site selection, initiation, monitoring, and close-out
  • CERs and PMCF plans
  • Clinical study reports
04

Quality management systems

Quality systems that fit the way your organization actually designs, manufactures, and supports devices.

  • QMS development
  • Audits and gap assessment
  • QMS implementation
  • Certification readiness
  • Regulatory Agency/Notified Body Support
05

Post-market compliance and surveillance

Ongoing support to keep products compliant and responsive after market entry.

  • Adverse-event support
  • Surveillance and regulatory updates
  • Complaint and feedback systems
  • Post-market clinical follow-up
06

Remediation, training, and technical services

Structured support when quality concerns, regulatory inspections and audits, or technical issues demand a clear response.

  • Root-cause and corrective action support
  • FDA 483 and warning-letter response support
  • Training and education
  • Microbiology, sterilization, biocompatibility, cleaning/reuse, packaging, and shelf-life expertise

NOT SURE WHERE TO BEGIN?

Start with the question that is holding your program back.

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