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!
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-entrepreneurs/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
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 |
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) |
|
US Market
| RIFC-US-01- ADV |
General Advisory |
| RIFC-US-02- PAT |
Planning Regulatory Pathway |
| RIFC-US-03- STD |
Standards Interpretation |
| RIFC-US-04- DOP |
Document Preparation |
| RIFC-US-05- DOR |
Document Review |
| RIFC-US-06- RMP |
Risk Management |
| RIFC-HP-01-ADV |
HIPAA General Advisory |
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
Client Testimonials
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
Supported by
