Services

Service offerings of RIFC

The following services are Now Operational.

click here to request an Introductory Meeting

  • General Advisory
  • Planning Regulatory Pathway New!
  • Standards Interpretation New!
  • Document Preparation& Review New!
  • Risk Management New!

RIFC Term Sheet & Agreement (184 KB) pdf

Service Code Title Overview 

Ask us a question and we shall get you an answer!

RIFC-01-ADV General Advisory

Request an Introductory Meeting.

Includes:

Covers expert recommendations on the global regulatory requirements for your device, from idea, to design a prototype, to market, to post-market.  Understand and realize applicable standards like BIS, ISO, ASTM, ANSI, and IEC. Know about the relevant laws, rules and statutory requirement of a county of interest.

Benefits:

Estimate timelines, cost, resources, and controls required at the various stages of device development and sale.

Outcome:

Reports and in person explanation.

RIFC-02-PAT

 

Planning the Regulatory Pathway

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Includes:

Covers most appropriate path for registration and securing regulatory approvals for your device. Know the exact class of the device, associated risk, documentation, and forms and dossier contents, templates. Know which government officials and offices to approach.

Benefits:

Have an action plan to kick off the approval process for a country of interest.

Outcome:

Reports and in person explanation.

RIFC-03-STD Standards Interpretation

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Includes:

Covers applicability of device-specific standards, the rationale behind using the standard and scientific methods of investigation during device design and packaging development to support the device safety, efficacy, effectiveness, and risk.

Benefits:

Avail Subject Matter Expert’s (SMEs) opinion and save time & money on selecting the appropriate scientific techniques in the boundaries of regulations.

Outcome:

Reports and in person explanation.

RIFC-04-DOC Document Preparation& Review

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Includes:

Covers hands-on training of important and mandatory documentation like standard operating procedures, validation protocols& reports, quality manual, Device Master File (DMF), Design History File (DHF), Site or plant master file, package inserts (IFU), primary and secondary packaging material symbols and text, etc.

Benefits:

Learn do’s and don’ts of a perfect document. Know the structure, contents, and control of documentation. Learn to prepare and to maintain quality documents.

Outcome:

Training manual and in person explanation.

RIFC-05-RMP Risk Management

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Includes:

Identification of the probability of occurrence of harm and severity of that harm of the device to patients or users. Application of techniques, procedures, policies to assess, controlling, communicating and reviewing the risk associated with the device.

Benefits:

Risk management attempts to identify and measure or mitigate the harm and gives you an opportunity to protect the public from harm/ injury arising from new medical devices or changes in the existing one.  Reduce risk to the patient. Reduce risk to the business.

Outcome:

Reports and in person explanation. Risk management plan, Risk report, and matrix.