Is your medical device in need of some attention? Design and manufacturing feel overwhelming? Thinking about how to get your device approved by the FDA??Regulatory compliance driving you up the wall? Device Design Solutions is here to take those pains away!?We are able to help in all aspects of your product development from ideation through design/development, regulatory clearance, and post-market support. We can also help with any business challenges that you are having. Contact us for a free consultation, [email protected]: Device Design Solutions https://lnkd.in/dfkAercw #medicaldevices #fda #iso13485 #iso62304 #iso62366 #researchanddevelopment #engineering #manufacturing #regulatoryaffairs #qualityassurance #qualitymanagement #strategy #strategicplanning #riskmanagement #culture #engagement #productdevelopment #productmanagement #projectmanagement #duediligence #mergersandacquisitions
Device Design Solutions
医疗设备制造业
San Diego,California 467 位关注者
Device Design Solutions was created to help you get your medical devices and systems completed on time and on budget!
关于我们
Device Design Solutions helps companies get their medical device systems completed on time and on budget so they can be approved by the appropriate regulatory agencies and released to the market. Project Rescue/Recovery -- We also have significant experience in working to get products/projects back on track and driving them through completion/product realization. Getting your products to market and in the hands of your customers and patients is vital to allow us to realize our mission of helping to improve human health. We also work with all companies in all industries on organizational improvement and growth opportunities! Let us help you get better, faster, and stronger! Contact us: [email protected] What we can do for you - * Executive Leadership * Management * Financial Planning/Budgeting * Strategy * Culture * Team Engagement and Accountability * Change Management * Risk Management * Research & Development (R&D) * Software Engineering * Hardware Engineering * Manufacturing * Product and Project Management * Global Staffing/Team Engagement and Management * Global Vendor/Partner Relationships * Mergers and Acquisitions (M&A) and Due Diligence * Quality Assurance * Verification/Validation * Regulatory Affairs * Intellectual Property (IP) “Let us help you plan, manage, execute, or rescue your regulated medical device development and help you overcome any organizational challenges and grow together!” - David Shanes, President
- 网站
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https://www.devicedesignsolutions.com/
Device Design Solutions的外部链接
- 所属行业
- 医疗设备制造业
- 规模
- 1 人
- 总部
- San Diego,California
- 类型
- 自有
- 创立
- 2017
- 领域
- Medical Devices、Research and Development、Software Engineering、Hardware Engineering、Product Management、Project Management、Quality Assurance、FDA、Global Vendor Management、Risk Mitigation、Risk Management、Process Improvement、Company Culture、Meeting Management、Systems Engineering、Product Strategy、Remediation、Product Development、CTO、Manufacturing、Regulatory Affairs、Systems Engineering、Change Management、Mergers and Acquisitions、Due Diligence、M&A、Intellectual Property、Quality Management Systems、ISO 13485、ISO 62304、ISO 62366、ISO 14971、Product Roadmap、FP&A、Meeting Management、Collaboration、Accountability、Employee Engagement、Succession Planning、Mentoring、Recruiting和Vendor Sourcing
地点
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主要
San Diego
US,California,San Diego,92128
Device Design Solutions员工
动态
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This is so beautiful; I love this!!! "Assume that I can and I will!"
This is the power of #advertising in action! Marketers have a responsibility to accurately portray ALL women and girls in the media. Brands have the power, the budget, and the influence to create meaningful and lasting change. It’s #WorldDownSyndromeDay and last year, CoorDown and Small New York in association with the National Down Syndrome Society, created an ad with a much-needed message: “Assume that I can, so maybe I will.” Marta Sodano, an Italian woman with #Downsyndrome, shared, “The whole point of this video is to end those stereotypes of people living with Down syndrome. Many times, people with disabilities are presumed to be unable to care for themselves or unable to make their own decisions and that’s not the case.” Our assumptions of those with Down syndrome shouldn’t determine their reality. Empower someone to fulfill their potential... and they probably will. ??
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I love this history of the popular programming languages; what a ride! This is a great graphic, thank you Dr Milan Milanovi?!
Chief Roadblock Remover and Learning Enabler | Software Development Expert | Author | Leadership & Career Coach | Building great products, building great teams!
?????? ???????? ?????????????? ?????????????????????? ?????????????????? ???????? - ???????? Check this exciting bar chart showing the most popular programming languages for the last 50+ years (6min). Popularity is defined as the percentage of developers using it actively or learning it. Winner by each decade: ?? ????????: ?????????????? ?? ????????: ???????????? ?? ????????: ?? ?? ????????: ?? ?? ????????: ???????? ?? ????????: ???????????? Who will be the winner in 2030? Credits: Data is beautiful (YouTube) -- ?? Reshare if you found this helpful. #technology #softwareengineering #programming #techworldwithmilan #data
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These are FANTASTIC lessons; read and learn them!
Retired Navy SEAL | LinkedIn Top Voice | Men Talking Mindfulness Podcast Co-host | I Post on Leadership, Wellness, & Humans being Good Humans | Subscribe to my newsletter below to get my 21 Day Mindfulness Course 4 FREE!
20 years of leadership lessons from the Navy SEAL Teams in 60 seconds - this isn't theory, it's lived experience. ?? Clarity beats control. → Confuse your team, & they become the enemy. ?? Trust is oxygen. → Leaders without it suffocate their teams. ?? Ego is friendly fire. → The need to 'win' costs real impact. ?? Over communication is a myth. → Think they've got it? Say it once more. ?? Hard conversations are the ultimate test. → Avoidance is delayed failure. ?? Speed is a weapon. → Perfect information is a luxury. ?? Self-leadership is the foundation. → Your burnout is their burnout. ?? Preparation determines outcome. → Competence isn't a bluff... it's battle readiness. Most painful lesson learned? Leadership isn't about you ... it's about making others capable. P.S. Which truth hit you hardest? Let me know in the comments ?? ?? Follow me (Jon Macaskill) for more battle-tested leadership truths... no fluff, just what works
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Hi network - reach out to David Albertif you can help him out here!
I am looking for a young scientist who would like to help me complete 4 scientific papers simultaneously. I have lots of the work done but there are lots of "i's" to dot and "t's" to cross to make sure the manuscripts fit the target journal's requirements. All four of these papers concern a new, disruptive cardiology product that has many applications on a global basis. It is designed to enable appropriate care access at reduced cost and move diagnostic capability to the patient- a trifecta of goals. Interested parties should email me at [email protected].
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These are terrific results, thanks for the information Ken Nelson!
Board Chairman & Investor @ CardiaCare | Partner @ MedTech Advantage Fund | Digital Health & MedTech Startup Board Member, Investor & Mentor @ HeartBeam, Acarix, Epitel, Echo IQ, Happitech, BloomLife, AHA, HRS, & HeartX
"AOP Health, an Austrian pharmaceutical company, has received?U.S. Food and Drug Administration (FDA)?approval for landiolol to be used in a critical care setting for the treatment of supraventricular tachycardia, including atrial fibrillation and atrial flutter. Landiolol, which will be sold under the brand name Rapiblyk, is an intravenous adrenergic receptor antagonist that acts fast; it is not intended to be taken for long periods of time to treat chronic cardiac arrhythmias. The FDA’s decision was based on data from a series of randomized trials. Overall, landiolol was associated with a decreased heart rate within 10 minutes in up to 90% of patients compared to up to 11% of patients given a placebo. Researchers defined a heart rate decrease as any reduction of at least 20% in a patient’s heart rate, a heart rate lower than 100 bpm or the intermittent cessation of the arrhythmia." American Heart Association Heart Rhythm Society #epeeps American College of Cardiology
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Way to go United States Naval Academy and Navy Football! Congratulations on your 10-3 season and BEATING ARMY...! (and, Air Force too) ?? ?? ??
Your 2024 Armed Forces Bowl Champions: The United States Naval Academy Midshipmen! ?? ?? ?? ??
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Check out this opportunity to work for a true innovator in the maternal health space! Bloomlife Inc is a GREAT to place to be a change-maker!
?? We're hiring at Bloomlife! Care to join a passionate team driven by the mission to improve the health of moms and babies through new technologies? We're looking for a Technical Project Manager, a Clinical Studies Engineer and a Software Engineer for our Liege or Eindhoven offices. More info on the link below. Reach out if you're interested or want to find out more. https://lnkd.in/gCc9KB_P Bloomlife Inc #hiring #womenshealth #maternalhealth #medicaldevices #projectmanager #clinicalstudies #softwareengineer