Regulatory is one of the most important goals of medical device companies in today’s market is launching and commercialization of their products globally. Get in touch with us for any enquiry!
With the growing usage of bioprostheses around the world, there has been a constant push to increase tissue durability. We describe a new treatment for bovine pericardium that combines phospholipid removal using octanediol-ethanol with glutaraldehyde neutralisation using taurine and storage in an aldehyde-free solution. Call us now!
Aortic valve repair and replacement are treatments used to address illnesses of the aortic valve, which is one of four valves that regulate blood flow through the heart. The aortic valve keeps blood flowing through the heart in the right direction. Contact us now!
Bridgemed’s practise and laboratory facilities have the techniques, equipment, and consultants necessary to evaluate innovative heart valve technologies such as transcatheter aortic and mitral heart valves (TAVR and TMVR), as well as surgical mechanical and bioprosthetic valves.
Manufacturer shall establish Quality Management System (QMS) and demonstrate compliance before regulatory approvals. Different countries require manufacturers to demonstrate compliance to the regulation that is applicable to that country where the products are intended to be marketed. boardboardboardboardboardboardboardboardboard
Bridgemed Solutions, Inc. offers a variety of tissue harvesting and selection options to meet manufacturer’s requirements. We are available to assist you at any moment. Call us now for any enquiry.https://www.bridgemedsolutions.com/tissue/
Our contract manufacturing services can help you get your fantastic transcatheter valve concept off the ground and into production fast and affordably. Our employees collaborate with your firm on a variety of levels to uncover and offer ways that help you save time and money. Get in touch with us now for any inquiry.
For the client’s transcatheter heart valves, we provide end-to-end manufacture, development, and support. We treat the tissue with an anti-calcification treatment as part of our service to ensure that the client’s animal tissue derived heart valve remains functioning for longer. Contact us now!
Driven by a desire to serve patients, the company works with the world’s top clinicians and researchers to address unmet healthcare needs. The Bridgemed team can handle the fatigue and structural testing of transcatheter heart valve frames.
For cardiac and vascular treatments, the Bridgemed’s bovine pericardial patch is a reliable option. We are a leading firm dedicated to offering medical solutions with a vision and bridging the gap between manufacturers and patients in order to improve healthcare.
We collaborate with doctors to develop solutions that will help people live longer, healthier, and more productive lives. We concentrate on medical innovations that target vast and expanding patient populations with unmet clinical needs. Contact us now!
We prepare the binder for each test for submission to regulatory agencies, assist with the production of submission paperwork, and give support for regulatory agency post-test queries if any arise. As a company representative, we contact regulatory bodies to explain testing requirements and answer any questions they may have. boardboardboardboardboardboardboardboardboard
Our consulting skills are based on our extensive knowledge of the medical device manufacturing business, including structural heart valves. We are one of the leading consulting businesses in this market because of our expertise in developing effective valve development techniques for TAVR, TMVR, or Tricuspid Pulmonic Valves using either bovine or pig tissue.
We are a medical device contract manufacturing organization and consulting firm that provides services to the industry. Our Contract Manufacturing Organization services will help you get your outstanding transcatheter valve concept off the ground and into production fast and affordably.
We are the leading Contract Manufacturing Organization (CMO) in the transcatheter heart valve area. We custom produce Transcatheter Aortic Valves (TAVR), Transcatheter Mitral Valves (TMVR) and Transcatheter Tricuspid Valves as per client requirements based on their IP.
Tissue Patch for Heart Valve is used by doctors during heart surgery to fix holes or tears in the valve. This tissue patch is available at Bridgemed and is created under the supervision of experts using high-quality materials.
The product was assessed and the ISO-10993 and FDA G#95 memorandum requirements were reviewed by a BridgeMed solutions expert. The tests advised by the labs, according to the research, are off-the-shelf assays that are not personalised to the product.