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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.

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.

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.

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.

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.

New!

Designing of the clinical investigation plan of medical devices and clinical performance evaluation of new In-Vitro diagnostic medical devices.

Benefits:

Understand the types of studies required to conduct for your devices as per the regulatory requirements. Get the complementary pathway and documentation review support.

Outcomes:

Study design and roadmap.

New!

Referrals and guidance for identifying suitable partners/ clinical trial sites (hospitals). Review of the data before submitting to the licensing the authorities.

Benefits:

Negotiations with the trial sites. Guidance on preparation of documents like Investigator’s Brochure (IB), Clinical Investigation Plan, Case Report Form (CRF), Informed Consent Form, Undertaking by the Investigator, Clinical Investigation Report, Periodic Safety Update Reports (PSURs).

Outcome:

Advice. Guidance. Referrals.