The new European Medical Devices Regulation (MDR) just came into force, with immediate application for new medical devices, generating an interesting debate. Some players welcome this major change, that will align national regulations, and believe it will help to remove from the market several medical devices with limited evidence and quality control.
Others highlight that the lack of enforcement of the directives in the past rather than the gaps in regulations originated a critical situation and therefore the need for a new MDR. Others still, argue that some of the new, more restrictive regulations might be detrimental to innovation.
For example, the classification of most medical software has shifted to class IIa or higher, thereby putting many start-ups and medical applications under pressure.
Irrespective of any personal opinion with regard to this regulation, the more demanding reviewing processes are meant to ensure safer and more effective solutions to the patient’s health conditions. As a non-exhaustive list of the key changes impacting our products and dossiers we can quote:
You will be able to find a more comprehensive overview on the changes in the Factsheet for healthcare professionals and health institutions , published by the European Commission.
At TRB Chemedica we believe in staying ahead of the curve and that is why we have taken a proactive stance towards being MDR compliant. Our OSTENIL line focused on rheumatology, has received the MDR approval and new registrations for OSTENIL, OSTENIL Plus and OSTENIL Mini as early as in the 1st quarter of 2022.
In a similar fashion, despite having still few years ahead until the deadline to switch our VISMED ophthalmology line over to MDR, our regulatory departments are extensively working to make sure our products will be ready for conformity assessments and seamless available on the European market.
TRB Argentina’s pharmaceutical plant manufactures a wide range of therapeutic solutions in rheumatology, pain management, infectious diseases and neurology. All its products meet the international GMP (Good Manufacturing Practices) standards, witnessing the high-quality standards and control processes TRB has been implementing since the foundation.
Nowadays, the facilities of TRB Argentina cover 8,300 sq. mt., dedicated to a comprehensive development of the pharmaceutical activity.
TRB Argentina’s main goal is to improve the quality of life for people. Its constant commitment is to ensure the highest quality of both products and services.
The cutting-edge technology of the manufacturing plants and the related pharmaceutical products control are applied to expanding therapeutic domains, including patients’ daily care.
The production facilities are constantly focused on environmental protection, implementing strict health and safety regulations in the workplace as well as adopting, among others, state-of the art methods for the treatment of liquid effluents.
A strong philosophy and a constant strive for improvement are the core model of TRB Argentina.
We are proud to celebrate the 20th anniversary of our Austrian subsidiary. Since 2002, the Vienna-based branch has strived to provide high-quality treatment options based on hyaluronic acid for osteoarthritis and dry eye symptoms. Thus, TRB Chemedica Austria has established itself as a competent partner for doctors, pharmacists, and patients in the fields of rheumatology and ophthalmology.
It is with great pleasure that we celebrate the 20th anniversary of our French subsidiary. As one of the first companies in France to commercialise intra-articular injections for osteoarthritis and later hyaluronic acid-based eye drops for dry eyes, TRB Chemedica France has become the local specialist of hyaluronic acid for ophthalmology, rheumatology and orthopedy.
We are glad to welcome you at TRB’s Isokinetic Conference Workshop on Saturday June 4, 2022, to discuss the benefits of hyaluronic acid in high impact sports. The workshop will focus on early osteoarthritis in athletes and hyaluronic acid in tendinopathies. Join us in Lyon to learn more about these topics and exchange with our panel of speakers.
Saturday, 4 June 2022, 16:30-18:00, Room Bellecour 3
|16:30-16:35||Introduction||Dr. Kal Parmar|
|16:35-16:50||Hyaluronic acid: unique features and biomedical opportunities||Pauline Cipriano-Bonvin, PhD|
|16:50-16:55||Q&As||Pauline Cipriano-Bonvin, PhD|
|16:55-17:15||Early osteoarthritis in athletes: causes and management||Prof. Waqar Bhatti|
|17:15-17:25||Q&As||Prof. Waqar Bhatti|
|17:25-17:45||Hyaluronic acid in tendinopathies||Dr. Jörg Dünkel|
|17:45-17:55||Q&As||Dr. Jörg Dünkel|
|17:55-18:00||Conclusion and closing remarks||Dr. Kal Parmar|
We invite you to come visit our booth n°29/30 in Lyon at the Isokinetic Conference from 4th-6th June 2022. From relieving tendinopathy to accelerating post-arthroscopy recovery, we will be happy to share our expertise in relevant and exciting fields at this landmark event in Football Medicine & Orthopaedic Rehabilitation.
Relieving pain and improving physical function is key in the treatment of osteoarthritis. This objective is particularly challenging in patients suffering from advanced OA, such as patients with Kellgren-Lawrence grade IV lesions or patients not eligible for joint replacement surgery. For long time, no new molecules have been successfully introduced in joint viscosupplementation. CM-chitosan is an innovative, naturally-derived glucosamine polysaccharide with lubricating and free-radical scavenging properties. Thanks to its unique structure, this molecule offers new opportunities in the treatment of advanced knee OA.
Please join us at our TRB Lunch Symposium on Friday 8th, chaired by Dr. Emmanuel Maheu, to learn more about the mechanism of action and the clinical efficacy of CM-chitosan. We are looking forward to meeting you there!
Mark your calendars. We’re excited to invite you to visit us at the 2022 Osteoarthritis Research Society International (OARSI) Hybrid World Congress in Berlin! From April 7th-10th we will be sharing our expertise in the field of osteoarthritis research, and how we aim to contribute in helping prevent, manage and cure this disease.
We look forward to meeting and exchanging with you.
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