medsysadvisor.blogspot.com

Medical Systems Advisor

Tuesday, October 21, 2014. POODLE, BEAST, Heartbleed: how secure is your “secure” medical device? The ability to remotely view, configure, and / or control any modern medical device in today's interconnected world is taken for granted - a device not having such capabilities right now might put the vendor at a great competitive disadvantage. So how can we know? What do you think? Wednesday, August 31, 2011. What Does "Regulatory Compliance" Mean? When you talk about "regulatory compliance" in the context ...

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Tuesday, October 21, 2014. POODLE, BEAST, Heartbleed: how secure is your “secure” medical device? The ability to remotely view, configure, and / or control any modern medical device in today's interconnected world is taken for granted - a device not having such capabilities right now might put the vendor at a great competitive disadvantage. So how can we know? What do you think? Wednesday, August 31, 2011. What Does Regulatory Compliance Mean? When you talk about regulatory compliance in the context ...

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Medical Systems Advisor | medsysadvisor.blogspot.com Reviews

https://medsysadvisor.blogspot.com

Tuesday, October 21, 2014. POODLE, BEAST, Heartbleed: how secure is your “secure” medical device? The ability to remotely view, configure, and / or control any modern medical device in today's interconnected world is taken for granted - a device not having such capabilities right now might put the vendor at a great competitive disadvantage. So how can we know? What do you think? Wednesday, August 31, 2011. What Does "Regulatory Compliance" Mean? When you talk about "regulatory compliance" in the context ...

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medsysadvisor.blogspot.com

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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...

2

Medical Systems Advisor: What Does "Regulatory Compliance" Mean?

http://medsysadvisor.blogspot.com/2011/08/what-does-regulatory-compliance-mean.html

Wednesday, August 31, 2011. What Does "Regulatory Compliance" Mean? When you talk about "regulatory compliance" in the context of Medical Systems, in addition to the well-known aspects of GMP/GCP/GLP FDA and the equivalent EU / Canada / Japan / China / etc. compliance standards, one must consider other, broader aspects of compliance such as the ones related to contracts, payments, anti-kickback, foreign corrupt practices, sustainability, carbon emissions, ROHS, OSHA, etc. Are you doing this already?

3

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?

4

Medical Systems Advisor: POODLE, BEAST, Heartbleed: how secure is your “secure” medical device?

http://medsysadvisor.blogspot.com/2014/10/the-ability-to-view-configure-and-or.html

Tuesday, October 21, 2014. POODLE, BEAST, Heartbleed: how secure is your “secure” medical device? The ability to remotely view, configure, and / or control any modern medical device in today's interconnected world is taken for granted - a device not having such capabilities right now might put the vendor at a great competitive disadvantage. So how can we know? What do you think? Subscribe to: Post Comments (Atom). POODLE, BEAST, Heartbleed: how secure is your “sec. Dan M Mihai – MedSysAdvisor. As a medic...

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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...

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priusmedical.com

Untitled Document

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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medsysadvisor.blogspot.com

Medical Systems Advisor

Tuesday, October 21, 2014. POODLE, BEAST, Heartbleed: how secure is your “secure” medical device? The ability to remotely view, configure, and / or control any modern medical device in today's interconnected world is taken for granted - a device not having such capabilities right now might put the vendor at a great competitive disadvantage. So how can we know? What do you think? Wednesday, August 31, 2011. What Does "Regulatory Compliance" Mean? When you talk about "regulatory compliance" in the context ...

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Just another WordPress.com site. POODLE, BEAST, Heartbleed: how secure is your “secure” medical device? Leave a comment ». The ability to remotely view, configure, and / or control any modern medical device in today’s interconnected world is taken for granted — a device not having such capabilities right now might put the vendor at a great competitive disadvantage. So how can we know? What do you think? October 21, 2014 at 3:28 pm. Posted in FDA Compliance. Leave a comment ». When you talk about “r...

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