Venture Center
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Manufacturing medical devices are challenging, and maintaining their quality, managing certifications, and meeting regulatory requirements is even more demanding. Managing all these aspects simultaneously can be overwhelming.

That's where our regulatory services come in!

We are here to make it easier for you to comply with regulations and streamline regulatory processes!

 

Get in touch

About RIFC

The Regulatory Information and Facilitation Center (RIFC) is a joint initiative of the Venture Center and BIRAC under the BIRAC Regional Bio-Innovation Center (BRBC) program.

We at RIFC aim to assist bio-entreprneurs/MedTech Startups in planning, seeking and securing regulatory approvals. We plan to achieve this by providing information in an entrepreneur-friendly manner, providing access to experts and regulators, providing access to practical insights from other entrepreneurs, providing services and organizing relevant and useful events.

Services We Offer

🆕 Membership Program

Exciting News for MedTech Startups!
Facing regulatory hurdles like limited expertise, fragmented knowledge, and high consulting fees?

RIFC is happy to announce the launch of a RIFC Membership Program, tailored to provide ongoing, flexible regulatory guidance to early-stage and growing startups.

Why join?

  • Get access to expert support
  • Startup-friendly plans
  • Help at key milestones – funding, trials, submissions

Our Termsheet

   Indian Market
RIFC-01-ADV

General Advisory

RIFC-02-PAT

Planning Regulatory Pathway

RIFC-03-STD

Standards Interpretation

RIFC-04-DOP

Document Preparation

RIFC-05- DOR

Document Review

RIFC-06-RMP

Risk Management

RIFC-07-CTP

Clinical Trial Study Plan

RIFC-08-CTA

Clinical Trial Advice

RIFC-09-INT

ISO 13485 Internal Audit

RIFC-10-DOC

ISO 9001 Document Review

 

Termsheet for India 

 European Market
RIFC-EU-01- ADV

General Advisory

RIFC-EU-02- PAT

Planning Regulatory Pathway

RIFC-EU-03- STD

Standards Interpretation

RIFC-EU-04- DOP

Document Preparation

RIFC-EU-05- DOR

Document Review

RIFC-EU-06- RMP

Risk Management

 

Clinical Trial Study Plan (Coming Soon)

 

Clinical Trial Advice (Coming Soon)

 

Termsheet for Europe

  US Market  

Key Resources

  • 26 National/International Standards (E.g. ISO 13485, ISO 10993, ISO 14971, ISO 9001 )
  • 150+ ISO 13485 and ISO 9001 QMS Templates
  • 250+ Dossier Templates (For India, EU and US regulations)
  • Database of the Testing Labs and Certification Bodies*

Key Activities

  • R-Clinic (Regulatory Clinic)
  • Workshops
  • Base camp focused on regulatory approval
  • Annual Conference

Activities Gallery

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Client Testimonials

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Recognition for RIFC

Received the Gold Award in the Service Enterprise category at the inaugural CII-AMTZ MedTech Quality Champion Awards 2024 at the 32nd Excellence Summit. This award recognizes Venture Center’s impactful regulatory services that empower medtech startups to succeed in the competitive healthcare sector. 

 

Our clients