Orthopedic Implants Services For Medical Equipment
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Manufactured by Lattice Medicalbased in FRANCE
A new era in medical application development. Thanks to its integrated platform, Lattice Medical is able to offer innovative solutions and the opportunity for biomedical projects to explore new technological landscapes. Lattice Medical is helping manufacturers in the medical procedure industry with their transition towards 3D technology. Lattice Medical is developing the first ISO 13485 ...
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based in UNITED KINGDOM
The new Medical Device Regulation (MDR) comes into force on the 26th May 2021 replacing the Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD). The MDR applies to all manufacturers selling medical devices into Europe and requires them to update both their processes and technical documentation to satisfy the new requirements. The MDR introduces greater ...
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by STEMartbased in USA
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro Diagnostics Directive (IVDD) 98/79/EC, which outline the safety and performance ...
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based in GREECE
CE Marking is the symbol as shown on the top of this page. The letters 'CE' are the abbreviation of the French phrase 'Conformité Européene' which literally means 'European Conformity'. The term initially used was 'EC Mark' and it was officially replaced by 'CE Marking' in the Directive 93/68/EEC in 1993. 'CE Marking' is now used in all EU official ...
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Manufactured by Puracon GmbHbased in GERMANY
Pre-validated and available immediately. Imagine you could reduce the lead time of your packaging solution from many months to 6 weeks while still saving money. That’s what we can offer you with our new pre-validated packaging. Our packaging concept for medical devices is flexible for a variety of products, it is easy to use and combines high-end quality and affordable investment costs. One ...
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Manufactured by Atrotech Oybased in FINLAND
Design, development and design transfer of Active Implantable Medical Devices (AIMD) Implanted electronics - Lead wires -Electrodes, Manufacturing of AIMDs, Wireless power transmission to implanted electronics Short-range bidirectional telemetry, System design and integration Biomedical - Mechanical - Electrical, Established quality and documentation system capable of supporting CE Mark / PMA ...
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Manufactured by ARCH Medical Solutions Corp.based in USA
Amplify will take your idea to market, from regulatory consults to FDA 510(k) submission. By using our Quality Management System, we can repeat the desired output of excellence and compliance. Our experience includes designing, developing, and manufacturing the first six FDA 510(k) cleared orthopedic implants on the Q10 ...
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Manufactured by Exparelbased in USA
Enhanced Recovery After Surgery (ERAS®) protocols are multidisciplinary perioperative care pathways. ERAS and multimodal protocols with EXPAREL improve postsurgical ...
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Manufactured by OSCOR Inc.based in USA
With over 35 years experience and with product certifications in over 70 countries, Oscor is the industry leader in the design and development of minimally invasive and implantable medical ...
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Manufactured by Cirtec Medicalbased in USA
Precision Drug Therapies: Often designed as active implants, these devices are increasingly helping to treat chronic pain, cancer, diabetes and other conditions. Typical designs comprise a reservoir for medication, a battery-powered pump programmed to release the medication at prescribed dosages and intervals and a catheter that serves as the delivery ...
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Manufactured by Laserod Technologiesbased in USA
Laser cutting of virtually any thin material is nearly always accomplished best by laser cutting, which performs with greater accuracy and less damage than any other method. Using a full array of Infrared and Ultraviolet wave lengths, Laserod has developed procedures for laser cutting of hundreds of types of material, ranging from softer materials (e.g., aluminum) to diamonds and very delicate ...
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based in GERMANY
High-quality, active implantable medical devices, such as pacemakers or cochlear implants, give patients new quality of life. EU Directive 90/385/EEC defines the requirements for active implantable medical devices on the European market. As a notified body, we conduct conformity assessments for your active ...
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based in USA
NOVO specializes in medical device development services for Class I, II, and III FDA-regulated devices. The scope of our ISO 13485:2016-certified quality management system (QMS) covers a five-phase product development process (PDP) from concept through manufacturing transfer, including support for clinical trials and regulatory submissions. Our medical engineering expertise encompasses both ...
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Manufactured by Echobio, LLCbased in USA
We do our testing in-house and regularly use the following equipment to characterize materials and validate medical implant designs: Bose 3230 Fatigue Test System. Mark-10 Quasi-static Load Frame. High Speed Rotary Bend Wire Testing. High Speed Rotary Bend Stent Testing. Stent Radial Force Characterization. Custom and Proprietary ...
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by ICON plcbased in IRELAND
ICON has experience with a range of bio-engineered and tissue-engineered products. We help clients to meet clinical, compliance and FDA CDRH, CBER and international regulatory ...
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Manufactured by Autocam Medicalbased in USA
We believe in being a long-term partner. This means working closely with your team, understanding your goals, and overcoming potential obstacles. At our core, we’re problem-solvers. From process improvement to speed-to-market responsiveness, value engineering to high-volume production, we’ve got you covered. To see how our partnership has served our clients, check out these case ...
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Manufactured by Owens & Minor, Inc.based in USA
Tracking bone and tissue implants require more record-keeping than other products used by hospitals. Documenting chain of custody with manual, paper-bound logbook entries, populating regulatory details, and tracing multiple data points to keep patients safe places demands on clinicians’ time–time that could be spent providing patient care. ...
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by Inotivbased in USA
We provide GLP and non-GLP nonclinical testing for the pharmaceutical and medical device industries. Our focus on superior service, advanced animal care, and ongoing commitment to excellence ensure your study’s success. We have multiple surgical suites, a team of trained veterinary surgeons, and state-of-the-art imaging ...
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by Metecon GmbHbased in GERMANY
An audit is the most effective method to establish certainty that you as the manufacturer or distributor of medical devices are in the position to meet all requirements. Metecon offers comprehensive support in this regard with a wealth of experience and know-how. Take a moment to get an overview of our services. And if you see any need, we look forward to discussing a solution with ...
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Manufactured by Gel4Med, Inc.based in USA
The Gel4Med approach is focused on nano-engineering the extracellular matrix to guide cell and tissue fate. Unlike using top down approaches with current biomaterials that rely on harvesting from tissue harvesting that often result in poor clinical outcomes due to variable quality of donor materials, donor availability, risk of disease transmission, extensive biochemical processing, donor-host ...
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