Medical Device studies
We support our sponsors in following activities:
◘ CA (Competent authorities) / EC submissions: We provide support in understanding the requirements of applicable approvals from relevant competent authorities, preparation of dossier, submission and its approval. We prepare EC dossier for its submission and approval.
◘ Conduct of study: Our experienced study team manages the study in order to collectrelevant protocol specific information / data, monitoring of clinical study as per monitoring plan, SAE management, data collection and its management. We ensure the data generated and collected throughout its duration is consistent with PMCF plan.
◘ Data handling and data clarification: our team of experts manages the entire process of data handling, analysis and assist in resolving data clarification to arrive at a meaningful study conclusion.
◘ Preparation of documents with respect to Clinical evaluation report (CER) like literature review protocol, clinical evaluation plan and reporting as per the Europe’s new Medical Device Regulation (MDR) by appraising the data’s relevance, applicability, quality, and significance.
◘ Regular updates to the CER are required as part of post-market surveillance and vigilance activities we do cater the same as a part of standalone activity
Clinical Studies for Medical Devices
Clinical trial in Medical device is one of the critical requirement for a Medical device company to get the device approved by the regulatory authorities. As a CRO, we support device manufacturers in collecting, recording and analyzing data generated from the device clinical studies including Post Marketing Clinical Follow up study.
Clinical Investigations
iVRS has deep domain experience in handling medical device clinical studies in compliance with applicable Medical Device (EU & US) Regulations requirements.
We have the experience to set up and manage clinical trials designed to demonstrate clinical safety and performance of a medical device for CE marking according to ISO 14155, as well as obtaining post-market surveillance clinical data on commercialized devices.
The ISO 14155 standard is released by the International Organization for Standardization (ISO). This affects all medical device manufacturers and is now the standard of reference for conducting medical device clinical studies in the EU countries, the United States, and Japan.
It is important for Medical Device Manufacturers to use the ISO 14155 standard to demonstrate compliance with EU requirements for clinical investigations.
The new MDR regulations state that medical device manufacturers must play an active role during the post-marketing phase, by implementing processes to actively and systematically collect, record and analyze data on the safety, quality and performance of the device throughout its expected lifetime.
We specialize in providing creative clinical solutions that balance quality, timelines, and budget using scientifically rigorous methods which includes as below:Clinical Project Management
◘ Clinical Consulting Services
◘ Ethics Committee/Competent Authority Submissions
◘ Essential Clinical Investigation Documentation
◘ Investigator’s Brochure (IB)
◘ Clinical Investigational Plan (CIP)
◘ Informed Consent Form (ICF)
◘ Case Report Form (CRF)
◘ Clinical Site Selection and Management
◘ Clinical Site initiation & Close out
◘ Source Data Verification / Monitoring
◘ Statistical Analysis
◘ Data Management
◘ Publication Policy
◘ Safety Narratives
◘ AE/SAE management and its reporting
◘ Clinical Trial Registration on clinicaltrials.gov
Clinical Monitoring
We are experienced professionals who can provide monitoring of your clinical procedures to verify that the device is used as you intended. Our clinical research associates guarantee up-to-date knowledge of your trial status at each participating hospital following Good Clinical Practices (GCPs).
We collaborate with clinical partners focused on biotechnology and medical device product research.
Post-Market Clinical Follow-up (PMCF) Studies
Post-market Clinical Follow-up (PMCF) is an important part of ongoing medical device regulatory compliance in the EU.
We can design and execute the PMS and PMCF studies in the context of the transition from the current Medical Devices Directive 93/42/EU (MDD) to the new Medical Devices Regulation (MDR 2017/745/EU), as well as how current PMCF activities can help in transitioning to the MDR.
Our expertise lies in the key domain knowledge of:
◘ How PMCF study requirements change under the MDR
◘ PMCF study requirements under the MDD
◘ The difference between a clinical investigation and a PMCF study
◘ Important considerations when conducting a PMCF study
Medical Writing & Reporting
Developing a regulatory document require strong understanding of scientific principles and technical expertise to correctly summarize the necessary data while making appropriate clinical inferences.
A CE Marking Technical File or Design Dossier (Class III) is a comprehensive description of the device which is intended to demonstrate compliance with European conformity standards. Compiling a technical file or design dossier is a critical step in Europe’s CE Marking Process which requires prime compliance with the Medical Devices Directive 93/42/EEC and the Medical Devices Regulation MDR 2017/745.
Our team possesses a significant knowledge and experience in technical documentation related activities which encompasses detailed information about the design, function, composition, use, claims, and clinical evaluation of the medical device.
Our workflow and attention to details ensures that the technical dossiers are customized to the device requirement. We are also equipped with the excellent review procedure for the technical documentation that must be further reviewed by a Notified Body (except for Class I device that is not provided sterile and does not have a measuring function). We have developed a significant understanding in how to assemble this information and present it for review by Notified Bodies is essential.
Your requirement of the technical documentation related to a medical devise will be delivered to its best levels by our processes of:
◘ Reviewing all existing documentation in support of meeting the applicable Essential Requirements / GSPRs.
◘ Evaluate and identify gaps or deficiencies in your documentation.
◘ Compile your EU Technical File or Design Dossier, with internal peer review.
◘ Determine applicable testing requirements and standards for your device.
◘ Designing customized literature search criteria and performing critical appraisal of the research findings.
◘ Review clinical data, compile a Clinical Evaluation Report (CER), and facilitate a Risk Assessment as necessary.
◘ Review proposed labeling and Instructions for Use.
As a team we have the experience of managing a number of medical device PMCF studies for our sponsor. We have managed clinical sites located in Germany, Denmark, Hong Kong and India. The scope of activity includes CA/EC submission, clinical site set up, project management, data management and study close out.
We support our sponsors in following activities:
◘ CA (Competent authorities) / EC submissions: We provide support in understanding the requirements of applicable approvals from relevant competent authorities, preparation of dossier, submission and its approval. We prepare EC dossier for its submission and approval.
◘ Conduct of study: Our experienced study team manages the study in order to collect relevant protocol specific information / data, monitoring of clinical study as per monitoring plan, SAE management, data collection and its management. We ensure the data generated and collected throughout its duration is consistent with PMCF plan.
◘ Data handling and data clarification: our team of experts manages the entire process of data handling, analysis and assist in resolving data clarification to arrive at a meaningful study conclusion.
◘ Preparation of documents with respect to Clinical evaluation report (CER) like literature review protocol, clinical evaluation plan and reporting as per the Europe’s new Medical Device Regulation (MDR) by appraising the data’s relevance, applicability, quality, and significance.
◘ Regular updates to the CER are required as part of post-market surveillance and vigilance activities we do cater the same as a part of standalone activity.
In Vitro Research Solutions Private Limited can provide state-of-the-art literature research and reviews on emerging technologies, MedTech innovations, and medical trends that can provide background summaries, reports, and manuscripts in the medical and scientific setting.
In Vitro Research Solutions Private Limited can provide state-of-the-art literature research and reviews on emerging technologies, MedTech innovations, and medical trends that can provide background summaries, reports, and manuscripts in the medical and scientific setting.
In Vitro Research Solutions Private Limited works with manufacturers preparing the following key reports.
◘ Clinical Investigational Plan (CIP) according to ISO14155 and MDR 2017/745
◘ Clinical Study Report (CSR)
◘ Clinical Literature Research and Report according to MEDDEV 2.7/1 Rev 4
◘ Clinical Evaluation Report (CER) according to MEDDEV 2.7/1 Rev 4
◘ Summary of Safety and Clinical Performance (SSCP) according to MDR 2017/745
◘ Post Market Surveillance (PMS) Plan
◘ Post Market Clinical Follow Up (PMCF) Protocol
◘ Investigator Brochure (IB) Development
Our Medical Writing deliverables are compliant with regulations, standards, and guidelines. The regulatory documents we prepare meet ISO 14155 and GCPs guidelines, MEDDEV 2.7/1 Rev 4 and MDR 2017/745 and applicable regulatory requirements. Our team has a comprehensive and critical understanding of the level of evidence required to meet the regulatory demands.
Let us talk
If you are an organization looking to engage a diligent, effective and reputed clinical research organization, you’ve come to the right place. InVitro Research Solutions was set up to help organizations like yours achieve integrity, speed and efficiency in your research requirements.
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Address
Bangalore, India
Call Us
+91 80 45500700
Email Us
info@ivrs.org.in