Case Study
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An Indian MNC established in the 1980s with business interests in various fields, including textiles. In 2020, they entered the medical industry with surgical masks and targeted entry into the US market.
- During the COVID-19 pandemic, the FDA introduced the Emergency Use Authorization (EUA) process to expedite the availability of medical devices and supplies.
- Identification of suitable predicate device.
- Identification of performance tests and the sample size required.
- We at RN identified the requirements related to surgical masks and it was found that a 510k clearance would be needed.
- One of the most important steps while applying for 510k is the identification of suitable predicate device. We identified a most appropriate predicate device by considering various factors like intended use, materials used, level of masks etc.
- By referring various relevant standards, RN identified the performance tests to be performed. There was some doubts regarding the sample size, which were cleared by reaching out directly to FDA. Testing was completed successfully based on the requirements as per standards applicable.
We at RN help you during the various phases of the project, from identifying applicable requirements to answering any questions the US FDA may have.
After submission, the US FDA had requested for some additional information. The AI response was submitted with justifications for the questions asked by FDA. Any corrections suggested by FDA to the 510(k) documents were also made.
The product got 510k clearance from the US FDA.
A medical technology company specializing in providing innovative solutions for patient monitoring, and connectivity systems. The company has played a significant role in developing telemetry systems, and integrated patient management systems. Their focus on patient safety, workflow efficiency, and clinician support has made them a reliable partner in hospitals, emergency departments, and critical care units worldwide.
- The device under evaluation though certified under MDD needed to be transitioned into MDR and the clients were unsure about the requirements to be fulfilled under MDR.
- The clients were facing difficulties related to a critical component of the clinical evaluation- the identification of an indicative list of outcome parameters.
- A template for the CEP and CER that meets the requirements under MDR needs to be developed.
- The indicative list of outcome parameters needs to be identified from state-of-the-art to demonstrate that the device under evaluation is as good or better than other devices currently available in the market.
RN being aware of the requirements under MDR has created a template that will check all boxes by the notified body.
A thorough literature search to identify the state-of-the-art and benchmark devices was conducted by the RN regulatory team to identify the suitable outcome parameters and acceptance criteria.
The notified body did not raise any non- conformities, and the device was CE certified under EU MDR.
A company established with the vision of supporting the government’s family planning program as a manufacturer of natural rubber latex condoms.
The natural rubber latex condom was a legacy device. The clients had received NCs from the notified body related to the PMS documentation and were not sure on how to address the comments.
Suitable templates need to be prepared for the PMS documentation which included:
- PMS plan
- PSUR
- PMCF plan
- PMCF report
Analysis of post-market data to identify any unwanted or previously unknown side-effects.
Templates for the various PMS documents were created based on EU MDR and relevant MDCG guidance by RN.
A PMS plan was prepared to plan, establish, document, implement, maintain and update a post-market surveillance system appropriate for the device.
All post market data available with the manufacturer like sales, complaints and trending data, publically available information related to the subject device and equivalent devices were analysed as part of the PSUR and relevant conclusions were drawn by the RN team.
Even though a class IIb device, due to its extensive use with minimal adverse events, RN suggested going ahead with a general PMCF activity- feedback from end users. The feedback forms have been distributed and the PMCF report will be prepared once sufficient number of responses is received.
This was accepted by the notified body.
A company manufacturing sterile natural rubber latex gloves for use by surgeons.
The product was to undergo initial conformity assessment and the manufacturer was not familiar with the certification process.
The manufacturer was ISO 13485 certified.
- Technical file needs to be created.
- Clinical evaluation which included a thorough literature needs to be performed by dedicated staff in various databases like PubMed, Cochrane, NICE etc.
- Indicative list of outcome parameters to be defined.
- Equivalence needs to be demonstrated to existing devices on the market.
The team from RN prepared the technical file including the clinical evaluation.
Suitable outcomes were identified from state-of-the-art as part of clinical evaluation. Since the device is undergoing initial conformity assessment, data from equivalent devices were used to demonstrate the safety and performance of the subject device.
All necessary documents were completed as per schedule.
The clients were happy with the quality of document delivered and have been submitted for Notified Body review.