We, Rescisco Global Regulatory consultants, intended to offer quality and regulatory services to the manufacturers of medical devices including in-vitro diagnostic medical devices from conceptualization stage to marketing as per the requirements.

Rescisco Global Regulatory Consultants > About Us > What We Do

What we do

Every Step of Your Product's Journey. Covered.

The path from innovation to patient impact has never been more complex — or more consequential. We provide end-to-end regulatory lifecycle management, so your product moves forward at every stage without compliance becoming a bottleneck.

"Bringing in regulatory expertise at the concept stage costs a fraction of what it costs to fix compliance failures at the submission stage. We help manufacturers understand that distinction — and act on it."

— Rescisco Global Advisory Practice

📍 The Rescisco Lifecycle Map — Concept to Commercialisation

1

Concept & Feasibility

2

Regulatory Strategy

3

Facility & QMS Setup

4

Design & Development

5

Testing & Validation

6

Clinical Evidence

7

Submission & Approval

8
Post-Market & PMS

What We Actually Do — Detailed

Before You Build

  • Market research & product feasibility analysis
  • Device classification advisory (CDSCO, FDA, EU MDR)
  • Intended use and indication-for-use definition
  • Regulatory pathway selection and timeline planning
  • DPR (Detailed Project Report) preparation
  • Intellectual property landscape review
  • Funding & grant proposal support (BIRAC, DST, DBT)
  • Facility design, layout, and clean room specification

While You Build

  • Design History File (DHF) and Device Master Record setup
  • Risk management plan (ISO 14971)
  • Biocompatibility planning (ISO 10993 series)
  • Software lifecycle documentation (IEC 62304)
  • Usability engineering (IEC 62366)
  • Sterilisation validation and packaging testing
  • QMS gap analysis and ISO 13485 implementation
  • Internal audit programme design

To Get Approved

  • CDSCO manufacturing/import licence applications
  • 510(k), De Novo, and PMA submissions (USFDA)
  • EU MDR/IVDR Technical Documentation & Notified Body support
  • MHRA UK, TGA, Health Canada, ANVISA, PMDA, NMPA dossiers
  • Clinical Evaluation Reports (CER) and Literature Reviews
  • Pre-submission meetings and query management
  • UDI registration and labelling compliance

After Approval

  • Post-Market Surveillance (PMS) programme management
  • Vigilance reporting and FSCA support
  • Periodic Safety Update Reports (PSUR)
  • PMCF planning and study execution
  • Regulatory change monitoring and impact assessment
  • Renewal, amendment, and variation management
  • Complaint handling procedure design