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Core Capabilities

Our Services

We offer comprehensive regulatory and quality compliance services tailored to your device type and target markets.

01

Regulatory Strategy & Submissions

Submission pathways for the US, EU, India, and beyond — planned around your device and its risk class.

  • US FDA 510(k), De Novo, and Pre-Submissions
  • EU MDR Technical Documentation & CE Marking
  • CDSCO Registration & Licensing (India)
  • Global market access planning (Australia, Canada, LATAM, APAC)
02

Quality Management Systems (QMS)

ISO 13485 systems designed to be audit-ready from the first internal audit onwards.

  • ISO 13485 QMS Design & Implementation
  • MDSAP Certification Support
  • Internal & Supplier Audit Programs
  • CAPA, Risk Management, and Post-Market Surveillance
03

Clinical & Biocompatibility Support

Clinical evidence and biocompatibility strategy built on literature, not assumption.

  • Clinical Evaluation Reports (CER) & PMCF Plans
  • Biocompatibility Testing Strategy (ISO 10993)
  • Literature Reviews & Gap Assessments
  • Clinical Trial Documentation & Regulatory Due Diligence
04

Technical Documentation & Labeling

Design history files, labelling, and registrations that hold up under review.

  • Design History Files (DHF) & Technical Files
  • Instructions for Use (IFU) & Labeling Compliance
  • UDI, GUDID, and EUDAMED Registrations
  • Sterilization & Packaging Validation Support
05

Post-Market Compliance

Staying compliant after launch — vigilance, reporting, and change impact assessment.

  • Vigilance Reporting & Adverse Event Management
  • Periodic Safety Update Reports (PSUR)
  • Recall Management & Field Action Support
  • Regulatory Intelligence & Change Impact Assessments

Ready to accelerate your regulatory pathway?

Tell us about your device and the markets you are targeting. We will come back with a clear view of the pathway and what it takes.

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