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Prius Medical Systems LLC
Dan Mihai
1817 S●●●●●● Drive
Hano●●●●Park , Illinois, 60133
United States
View this contact
Prius Medical Systems LLC
Dan Mihai
1817 S●●●●●● Drive
Hano●●●●Park , Illinois, 60133
United States
View this contact
Prius Medical Systems LLC
Dan Mihai
1817 S●●●●●● Drive
Hano●●●●Park , Illinois, 60133
United States
View this contact
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Prius Medical Systems LLC | priusmedical.com Reviews
https://priusmedical.com
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priusmedical.com
Untitled Document
http://www.priusmedical.com/about.html
Additionally, most of our senior partners have a strong business background in this space, having participated in strategic planning, technology roadmapping, business development, mergers and acquisitions, due diligence activities, and post-merger integration efforts. Dan M Mihai, MBA. Dan has 12 patents related to medical devices and healthcare informatics, holds both MS-EE and MBA degrees, and is a graduate of the Executive Development Program at the University of Chicago.
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http://www.priusmedical.com/home.html
Download our free whitepaper. On our new revolutionary OnTrack. Quantitative program management methodology and find out what all that buzz is about! Your Medical Systems Program? Worried about your Medical Device, Quality System, or eHealth Program? Whatever the reason, we have your answer. Contact us now at info@priusmedical.com. For a free initial cosultation. And should you choose to employ our proprietary OnTrack. Whether it's compliance-related activities such as systems or software verification, r...
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http://www.priusmedical.com/services.html
Our planning services include:. Compliance-driven planning, including evaluation of the non-conformance situation (483s, warning letters, consent decree), gap analysis, action plan, resource plan, budget development, plan optimization. Performance-driven planning, including evaluation of the performance gap situation (financial limitations, resource limitations, time constraints), gap analysis, action plan, resource plan, budget development, plan optimization. Our compliance services include:.
Untitled Document
http://www.priusmedical.com/events.html
Drug Information Association - 44th Annual Meeting, Boston, MA. June 25, 2008: Outsourcing Computerized Systems. Managing Consultant, CausePoint Consulting. Martin Browning, MS. President, EduQuest, Inc. June 26, 2008: Infrastructure, Hardware, Computerized Instrumentation. Dan M Mihai, MBA. Managing Consultant, Prius Medical Systems LLC. Martin Browning, MS. President, EduQuest, Inc. We're sorry that you missed the conference event. Click here to download the presentation slides and bonus materials.
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http://www.priusmedical.com/careers.html
Are you an established industry veteran with a sizable network of key contacts in the field? Are you a highly successful manager with a proven track record of successful offshoring or managing multinational teams in the FDA-regulated space? These are exciting times at Prius Medical Systems. Independent of the current openings, if you are the best in what you do and everybody in the industry knows it, then we want to talk to you. Send us an e-mail at careers@priusmedical.com. And we'll be in touch.
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Medical Systems Advisor: May 2011
http://medsysadvisor.blogspot.com/2011_05_01_archive.html
Tuesday, May 17, 2011. Top 7 Due Diligence Pitfalls – How To Avoid? So you are contemplating the acquisition of a small company with an exciting product and technology that seems to complement your own. The few early adopters seem relatively pleased, your marketing team is quite excited about the market potential, and the financial model (based on the proverbial “hockey stick” sales forecast) seems to work out. Your legal team gives you the green light as well. The underlying technology is a solution loo...
Medical Systems Advisor: My program is late – yet again. What to do?
http://medsysadvisor.blogspot.com/2011/05/my-program-is-late-yet-again-what-to-do.html
Friday, May 6, 2011. My program is late – yet again. What to do? There are always good reasons. The engineering estimate was overly optimistic. The requirements were not well defined. Your key piece of technology needs a little more “tweaking”. The contractor you hired works too slow and their output needs too much rework. And so on. Determine the root cause(s) for the delays. How were the requirements captured? Was the technical approach selected before the requirements were captured? Why or why not?
Top 7 Due Diligence Pitfalls – How To Avoid? | medsysadvisor
https://medsysadvisor.wordpress.com/2011/05/18/top-7-due-diligence-pitfalls-–-how-to-avoid
Just another WordPress.com site. Top 7 Due Diligence Pitfalls How To Avoid? Leave a comment ». So you are contemplating the acquisition of a small company with an exciting product and technology that seems to complement your own. The few early adopters seem relatively pleased, your marketing team is quite excited about the market potential, and the financial model (based on the proverbial hockey stick sales forecast) seems to work out. Your legal team gives you the green light as well. 1 The underlying t...
Medical Systems Advisor: FDA audit next week – how to prepare? Five easy steps
http://medsysadvisor.blogspot.com/2011/05/fda-audit-next-week-how-to-prepare-five.html
Thursday, May 12, 2011. FDA audit next week – how to prepare? You are a medical device manufacturer or service provider and you have just received a FDA Form 482 (Notice of Inspection) stating an inspection start date a week from today. What can you do to improve your odds of success? Step 1. Determine the type of audit – pre-announced inspections (like this one) can be of two main types:. Step 2. Most auditors will request a copy of your firm’s Quality Policy and high level Procedures (includi...If you ...
Medical Systems Advisor: April 2011
http://medsysadvisor.blogspot.com/2011_04_01_archive.html
Tuesday, April 26, 2011. Risk Based Compliance - A Panacea? Risk-Based Compliance (RBC) seems to be the new buzzword in compliance circles these days. Touted by consultants to minimize compliance costs, improve compliance outcomes, and secure greater management support for compliance activities, RBC looks, feels, and sounds like a good idea. Should we all jump on the bandwagon then? Most RBC strategies include the following (or similar) tactical steps:. 5 Plan and implement the chosen compliance measures.
Medical Systems Advisor: How to best respond to an FDA 483 letter?
http://medsysadvisor.blogspot.com/2011/05/how-to-best-respond-to-fda-483-letter.html
Monday, May 2, 2011. How to best respond to an FDA 483 letter? Let’s face it, receiving a Form 483 letter (Notice of Inspectional Observations) from the FDA has never been much fun. And since the September 2009 change to the statutory response time (now 15 days) there isn’t that much time to react. What to do? Your RM should prepare a tracking spreadsheet with the following content:. The observation as worded in the 483 letter. Name of responsible individual. Due date for response draft. Some 483 observa...
Medical Systems Advisor: How to verify CAPA QSR compliance - 5 key elements
http://medsysadvisor.blogspot.com/2011/05/how-to-verify-capa-qsr-compliance-5-key.html
Wednesday, May 11, 2011. How to verify CAPA QSR compliance - 5 key elements. CAPA-related QSR requirements are quite far reaching. If you are coming from a manufacturing background, CAPA is conceptually similar with Six Sigma’s DMAIC methodology (Define / Measure / Analyze / Improve / Control) with a few key differences. Back to the question - to be compliant with the QSR, your CAPA system must have adequate procedural and operational coverage for the following five key elements:. E CAPA Effectiveness st...
Medical Systems Advisor: Top 7 Due Diligence Pitfalls – How To Avoid?
http://medsysadvisor.blogspot.com/2011/05/top-7-due-diligence-pitfalls-how-to.html
Tuesday, May 17, 2011. Top 7 Due Diligence Pitfalls – How To Avoid? So you are contemplating the acquisition of a small company with an exciting product and technology that seems to complement your own. The few early adopters seem relatively pleased, your marketing team is quite excited about the market potential, and the financial model (based on the proverbial “hockey stick” sales forecast) seems to work out. Your legal team gives you the green light as well. The underlying technology is a solution loo...
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