Case Study on Clinical Evaluation of Prosthodontic products
Geography: N/A
Type Service: N/A
Background/Client Requirement:
A prominent international producer of Prosthodontic devices, renowned for its groundbreaking advancements in Dental health/hygiene, outsourced Techsol Lifesciences to craft clinical evaluation Report (CER) for their dental products and surgical devices, ensuring compliance with the EU MDR 2017/745 and TGA standards.
Project Objective:
The aim was to develop and uphold essential components of the CE technical documentation for regulatory submissions of medical devices in the EU and TGA, including the Clinical Evaluation Report (CER), Clinical Evaluation Plan (CEP), and Literature Search Reports (LSR).
Techsol Approach:
This involved conducting a thorough systematic literature review on the medical device and State-of-the-Art, assessing both non-clinical and clinical data provided by the manufacturer and to incorporate real-world evidence from adverse event databases. Furthermore, conducting a robust analysis of the devices’ safety, performance, and benefit-risk profile to ensure compliance along with General Safety and Performance Requirements outlined in the EU MDR.
Techsol provided support to the company for various activities related to their Class I, IIa, and IIb devices, including:
- Authoring CEPs, CERs, and LSRs to ensure compliance with EU MDR 2017/745.
- Evaluating the sufficiency of clinical data by analyzing product history, pre-clinical and clinical studies, complaints, adverse events, and literature.
- Swift processing and analysis of large volumes of data, facilitating rapid literature review.
Challenges:
Managing a high volume of literature hits and post-market data presented several challenges:
- Data Overload: Sorting through a large number of literature hits and post-market data was overwhelming, leading to information overload and difficulty in identifying relevant insights in short time.
- Data Quality: Ensuring the quality and reliability of the literature and post-market data was crucial. With a high volume of data, there was an increased risk of encountering low-quality or irrelevant information, which could have impacted decision-making.
- Timeliness: Processing a large amount of data within tight timelines was challenging. Delayed analysis could have impeded timely decision-making or regulatory compliance.
- Techsol collaborated closely with the client to craft a comprehensive literature search strategy, pinpoint analogous devices, and scrutinize the amassed clinical data derived from the device’s market utilization.
- Created search strings for extensive search of available literature
- The Techsol team authored the Clinical Evaluation Plan and Report, encompassing the Literature Search Report, in alignment with EU/MDR 2017/745 and MEDDEV 2.7/1 Rev.04 standards. Modifications were made to the literature search strategy for the Clinical Evaluation Report to harness data pertaining directly to the treatment modality, ensuring the development of a comprehensive State of the Art discussion.
- Evaluated the sufficiency of clinical data by examining product history, pre-clinical and clinical studies, reports of complaints and adverse events, as well as evidence collected from literature reviews and state-of-the-art analyses.
Project Achievements:
Techsol continues to deliver regulatory documentation via an end-to-end process involving the right stakeholders to achieve:
Comprehensive Documentation: Our team successfully authored CERs, ensuring comprehensive documentation of the clinical evaluation process for each medical device. This included detailing the methodology, data sources, analysis, and conclusions drawn.
Regulatory Compliance: The CERs were crafted meticulously to meet the stringent regulatory requirements of EU MDR 2017/745. By adhering to regulatory guidelines, the company demonstrated its commitment to ensuring the safety and efficacy of its medical devices. > 98% quality & timeline delivery performance despite tight timelines, an achievement in collaborating with Techsol’s expertise
- Improved compliance based on guidance from Techsol’s regulatory experts
- Evidence-Based Approach: Our team utilized an evidence-based approach, incorporating a systematic literature review, literature review, evaluation of clinical and non-clinical data, and real-world evidence from adverse event databases. This rigorous methodology strengthened the credibility and reliability of the CERs.
- Techsol’s constant support in clinical evaluation documentation, coupled with industry best practices, has been instrumental in the partnership’s success. This achievement is attributed to the collaboration between experienced resources and the client’s regulatory team. Through leveraging Techsol’s expertise, multiple documents are delivered swiftly, meeting expedited timelines without compromising quality. This streamlined approach ensures compliance with regulatory standards while maximizing efficiency.