REGULATORY AFFAIRS AND QUALITY MANAGEMENT

Medical devices, healthcare cloud platforms, and services must comply with regulations throughout the device lifecycle. Data privacy and security are critical, as compliance issues can significantly impact business.

For every project, we apply a detailed regulatory strategy and homologation plan to ensure timely submissions and certifications. Our 'Design for Safety' and 'Design for Security' approach keeps the "Patient first," ensuring safety, security, and reliability

Product Compliance for FDA & EU MDR

We help MedTech companies navigate the complex regulatory landscape to achieve product compliance for US FDA clearance and EU MDR CE certification. Our experienced team provides comprehensive support throughout the product development lifecycle to ensure timely and successful approvals.

Our services include:

  • Regulatory strategy and device classification
  • Support preparing the Design History File (DHF) and Medical Device Files
  • Technical File readiness for EU MDR compliance
  • Usability risk analysis and HF validation tests support
  • Clinical Evaluation Reports (CER) per EU MDR and India I-MDR
  • Support the Regulatory tests and reports review
  • Product Technical publication documentation per regulatory requirements
  • Comprehensive and effective Regulatory submissions and follow-up

Product Compliance for India

We assist MedTech companies in achieving compliance with CDSCO (Central Drugs Standard Control Organization) requirements for the Indian market. Our services are designed to streamline the certification process for both import and manufacturing licenses.

Our support includes:

  • Device classification and regulatory pathway guidance

  • Coordination of product testing as per CDSCO requirements

  • Preparation of technical documentation and dossiers

  • Application support for import and manufacturing licenses

  • Clinical evaluation documentation and submission readiness

Post-Market Surveillance (PMS) & PMCF Management

We offer comprehensive Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) management services to help you maintain compliance with regulatory requirements across key markets, including the US and EU.

Our services include:

  • Complaint handling and adverse event reporting (AER) in compliance with FDA 21 CFR Part 803
  • Preparation and submission of PMS reports for FDA and EU regulators
  • Development of PMCF Plans and PMCF Evaluation Reports in line with EU MDR Chapter VII
  • Preparation of Periodic Safety Update Reports (PSUR)
  • Vigilance reporting and coordination with notified bodies and competent authorities

Product Compliance for FDA & EU MDR

We help MedTech companies navigate the complex regulatory landscape to achieve product compliance for US FDA clearance and EU MDR CE certification. Our experienced team provides comprehensive support throughout the product development lifecycle to ensure timely and successful approvals.

Our services include:

  • Regulatory strategy and device classification
  • Support preparing the Design History File (DHF) and Medical Device Files
  • Technical File readiness for EU MDR compliance
  • Usability risk analysis and HF validation tests support
  • Clinical Evaluation Reports (CER) per EU MDR and India I-MDR
  • Support the Regulatory tests and reports review
  • Product Technical publication documentation per regulatory requirements
  • Comprehensive and effective Regulatory submissions and follow-up

Product Compliance for India

We assist MedTech companies in achieving compliance with CDSCO (Central Drugs Standard Control Organization) requirements for the Indian market. Our services are designed to streamline the certification process for both import and manufacturing licenses.

Our support includes:

  • Device classification and regulatory pathway guidance

  • Coordination of product testing as per CDSCO requirements

  • Preparation of technical documentation and dossiers

  • Application support for import and manufacturing licenses

  • Clinical evaluation documentation and submission readiness

Post-Market Surveillance (PMS) & PMCF Management

We offer comprehensive Post-Market Surveillance (PMS) and Post-Market Clinical Follow-up (PMCF) management services to help you maintain compliance with regulatory requirements across key markets, including the US and EU.

Our services include:

  • Complaint handling and adverse event reporting (AER) in compliance with FDA 21 CFR Part 803
  • Preparation and submission of PMS reports for FDA and EU regulators
  • Development of PMCF Plans and PMCF Evaluation Reports in line with EU MDR Chapter VII
  • Preparation of Periodic Safety Update Reports (PSUR)
  • Vigilance reporting and coordination with notified bodies and competent authorities

Insights & Innovations

Our Success Stories

The iOrbit Edge

Deep Regulatory Expertise

Strong command of global regulations (FDA, EU MDR/IVDR, CDSCO, etc.) across medical devices, pharmaceuticals, and digital health.

Proven Track Record of Approvals

Demonstrated success in obtaining 510(k) and other regulatory clearances, with real case references.

Strategic Regulatory Guidance

Ability to define optimal regulatory pathways, minimize approval risks, and align compliance with business goals.

Global Regulatory Reach

Capacity to support multi-region submissions and maintain compliance in diverse markets through in-house or affiliated experts.

Process-Driven with Audit Readiness

Strong documentation, gap assessments, and preparedness for inspections and audits by regulatory bodies.

Adapts to emerging regulations.

Keeps pace with evolving areas such as AI/ML in healthcare, SaMD, cybersecurity, and real-world evidence requirements.