Quality
& Regulatory Services
  • Custom Design & Development
  • Complete System Overhaul
  • System Implementation

The Orchid Difference

Orchid’s Expert Regulatory Team Services —
  • Submission Strategies
  • Comparative Testing

  • Pre-market Notifications
  • PMA Submissions
  • Canadian Licensing
  • FDA Registration
  • Foreign Device Services
  • Recall Guidance
Technical Writing Assistance

Orchid can take over writing tasks for technical system procedures, official manuals and design dossiers.

Auditing Services

Our regulatory team will audit your complete system including internal, supplier and due diligence.

Personnel Training

Let us train your team to be compliant with ISO 13485, FDA QSR (GMPs) and corrective actions.

Continuous Improvement

Keep your system updated with our improved efficiencies, plant reconfiguration and lean manufacturing initiatives.

Ensure your Quality System is an Efficient Pathway to Commercial Success
Quality & Regulatory Services
1. Quality Systems Services

Leverage Orchid to develop and implement your customized quality system into your business. 

  • Authoring & technical writing (Procedures, Manuals)

  • Personnel training

  • Mock FDA inspections
  • Risk management
2. Auditing Services
  • Supplier
  • Due diligence
  • Continuous improvement/gap assessments
  • ISO 13485, FDA QSR (GMPs), Europe MDD
3. Regulatory Services

Orchid can help you with submission strategy development including device classification & predicate selection.

  • Comparative testing identification

  • 510(k) pre-market notifications

  • PMA submissions
  • CE mark/technical files & design dossiers

Next Steps: Consult a Quality or Regulatory Specialist

Leverage Orchid to Maximize Your Project