Clinical research for pharmaceuticals and devices follows the same general path. The first trial is a small pilot study to gain insight on how a larger study should be designed based on preliminary safety and efficacy data. Read more in our latest blog post: https://hubs.ly/Q02Z3Zyp0
关于我们
MED Institute supports consultants, manufacturers, and developers of medical products through the key phases between the start of an idea and making a product available to clinicians and patients. With more than 40 years of experience in medical device testing, engineering, data analysis, global regulatory submission preparation, and clinical trials, our team knows what it takes to guide a product through all the complex steps required for market approval. Contact us today to learn how we can partner with you medinstitute.com | 855.463.1633.
- 网站
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https://medinstitute.com/
MED Institute的外部链接
- 所属行业
- 商务咨询服务
- 规模
- 11-50 人
- 总部
- West Lafayette,IN
- 类型
- 私人持股
- 创立
- 1983
- 领域
- Medical Device Testing、Global Regulatory Submission Preparation、Clinical Trials、Solving Problems、Engineering、Data Analysis、Medical Device Engineering、MRI Safety、Scientific Communications、Device Assembly、Computational Modeling and Simmulation、Regulatory、Device deisgn and development、Regenerative Medicine、Pre-Clinical Animal Studies、Pre-Clinical Biological Studies、FDA Remediation Services、Biological Evaluations、Emergency Use Authorizations和Clinical Evaluation Plans and Reports
地点
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主要
1330 Win Hentschel Blvd, Suite100
US,IN,West Lafayette,47906
MED Institute员工
动态
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Have you been looking for a company or vendor to add to your Preferred Vendor list? MED Institute is excited to partner with your company and meet or exceed your expectations as a preferred vendor. https://hubs.ly/Q02XL6c80
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Look for Samantha Stevenson, CST/CSFA, CCRP and Abby Anttila at #TCT2024. They're happy to share more about how our services can support your project needs.
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If you missed our tech talk presented by Justin Metcalf at MD&M Minneapolis last week, please get in touch with us to learn more about particulate testing in medical devices. https://lnkd.in/g8YEiast
Great presentation from Justin Metcalf on particulate testing in medical devices. After the talk, we touched on how manufacturers are handling testing for devices already on the market. There’s definitely some resistance, we see this especially in the EU, where upclassified products now require additional testing to stay compliant. The pain is real, and it’s going to take time for manufacturers to fully accept the new regulatory demands. #medicaldevices #ADMMinn
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Decentralized clinical trials (DCTs) are becoming increasingly popular, with the increased use of electronic systems and novel techniques for centralized monitoring. Our latest blog post summarizes the advantages of decentralized trials and suggest ways to overcome challenges. https://hubs.ly/Q02VKHFh0 What are your thoughts on decentralized clinical trials?
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When conducting a clinical trial, we actively monitor not just the data, but study site performance and compliance with applicable regulatory requirements. Active clinical monitoring can help predict potential clinical trial challenges early so they may be addressed before they lead to significant delays and increased costs, or derail the trial completely. What clinical trial challenges are you facing? #clinicaltrials #medicaldevices
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If you want to hear more information regarding MRI safety evaluations, catch David Gross (MED Institute) speaking at the #OSMAFallMeeting2024!
Uncertain about common deficiencies in MRI safety evaluations? Gain valuable insights from expert David Gross (MED Institute) at the #OSMAFallMeeting2024! Be a part of our 70th Anniversary Celebration! Join us October 22-24 at the Renaissance Baltimore Harborplace Hotel. Visit https://lnkd.in/d4mZW5hQ to register and learn more! #OSMA #celebrating70years #orthopedics #medicaldevice #regulatoryaffairs #MRIsafety
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If you're interested in hearing more about B1+RMS in regards to your MRI Safety Labeling, catch Grant Baker (MED Institute) at the #OSMAFallMeeting2024!
Do you have questions about #MRI Safety Labeling? Join us on October 23 at the #OSMAFallMeeting2024 as Grant Baker from MED Institute explains B1+RMS and how it affects MRI Safety Labeling. Register for the #OSMA Fall Meeting and be a part of our 70th Anniversary Celebration! Don't delay- the discounted hotel rate ends this Sunday, September 22. Check your member email for registration and hotel links. #celebrating70years #orthopedics #medicaldevice #regulatoryaffairs