As part of Qualtech's dedication to excellence and continuous learning, we had the privilege of hosting a captivating talk by the esteemed Dr. Huang Wen-Chien, M.D., Ph.D. (黃文傑) on June 29.
Dr. Huang, an expert in the fields of thoracic surgery and molecular oncology, shared with us his knowledge and expertise in the field. Currently serving as the director of the Division of Thoracic Surgery at Mackay Memorial Hospital, he delivered an enlightening presentation titled "The Evolution of Minimally Invasive Treatment for Early Lung Cancer." Listening to Dr. Huang is Qualtech’s own team of medical writers and clinical evaluators, who diligently take notes and absorb the valuable insights. Therefore, we would like to share a summary of the presentation below, highlighting the current trends in the field of thoracic surgery.
Significant advancements in minimally invasive techniques have transformed traditional lung cancer surgery. In the past, surgeries involved larger incisions and invasive procedures, but now three-port, two-port, and one-port approaches have emerged, resulting in smaller incisions, faster recovery, and improved patient comfort. The integration of robotic surgery has also further revolutionized lung cancer treatment by providing surgeons with enhanced precision, dexterity, and control. This cutting-edge technology enables accurate navigation through delicate lung tissue, leading to better outcomes for patients.
Non-surgical treatment modalities such as Photodynamic Therapy (PDT) and Radiofrequency Ablation (RFA) have also advanced. PDT uses light and a photosensitizing agent to selectively destroy cancer cells, while RFA targets and eradicates tumors using heat. These non-invasive options serve as alternatives for patients who may not be suitable for surgery or prefer less invasive interventions.
Another emerging technology in thoracic surgery is Video-Assisted Thoracic Surgery, or VATS. VATS is a minimally invasive procedure used for lung cancer surgery as well as other chest procedures. During VATS, a thoracoscope, a small tube with a camera, is inserted through a small incision between the ribs. This allows the surgeon to visualize the entire chest cavity without the need for extensive chest opening or rib spreading. Using specially designed instruments inserted through additional small incisions, the surgeon can remove diseased lung tissue and lymph nodes.
At Qualtech, we recognize the critical role of Clinical Evaluation Reports (CERs) in the registration process for medical devices. CERs serve as important tools for regulatory authorities to make informed decisions about the approval of medical devices. We offer comprehensive CER services to assist you in this aspect, ensuring smooth market entry in the EU and China.
Our team of medical writers, equipped with clinical experience and expertise in biomedical engineering and molecular biology, is well-prepared to provide you with high-quality CER writing services. We cater to your specific requirements and offer our expertise in preparing CERs for the European Union, China, Singapore, and other regions.
Our range of services includes conducting searches for similar products, performing literature searches in major databases both domestically and internationally, searching for adverse events after product listing, integrating clinical literature and non-clinical data, and ultimately, writing the clinical evaluation report.
We take pride in our successful track record of assisting numerous clients in composing CERs to obtain the CE mark and China NMPA certificates. Our experience spans across various medical devices, including electric therapy equipment, electrocardiographs, anesthetic ventilators, ceramic primers, contact lenses, bone cements, suture threads, and many more.
Allow us to showcase how our CER service can be of assistance to you by exploring these two case studies featuring the successful registration of two new products in the Chinese market:
With Qualtech's expertise and support, you can confidently navigate the complex landscape of CERs and ensure compliance with regulatory requirements for your medical devices. We are committed to delivering comprehensive and reliable CER services to facilitate your market access and success. To see our most up-to-date promotions and events, you may find us on Facebook.
References:
- https://www.qualtechs.com/en-gb/qt-activity-clinical-evaluation-report-cer-services-
- https://www.qualtechs.com/en-gb/clinical-trial
- https://www.qualtechs.com/en-gb/register/67
- https://www.qualtechs.com/en-gb/register/70