softwareregulatory.com softwareregulatory.com

softwareregulatory.com

Software Regulatory

Software Regulatory focuses on the regulatory aspects of software used in medical devices and in clinical trials.

http://www.softwareregulatory.com/

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CONTACTS AT SOFTWAREREGULATORY.COM

Software Regulatory, LLC

Robert Beck

7800 co●●●●●●●d 110 w

Minn●●●●ista , MN, 55364

US

1.95●●●●0297
ro●●●●●●●●●@softwareregulatory.com

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Software Regulatory, LLC

Robert Beck

7800 co●●●●●●●d 110 w

Minn●●●●ista , MN, 55364

US

1.95●●●●0297
ro●●●●●●●●●@softwareregulatory.com

View this contact

Software Regulatory, LLC

Robert Beck

7800 co●●●●●●●d 110 w

Minn●●●●ista , MN, 55364

US

1.95●●●●0297
ro●●●●●●●●●@softwareregulatory.com

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PAGE TITLE
Software Regulatory | softwareregulatory.com Reviews
<META>
DESCRIPTION
Software Regulatory focuses on the regulatory aspects of software used in medical devices and in clinical trials.
<META>
KEYWORDS
1 CFR 21 Part 11
2 FDA Regulatory Consultant
3 Software Validation
4 software life cycle Verification and Validation
5 Change Control
6 Software required in medical devices
7 510(k)
8 510k
9 PMA
10 medical device software development FDA software quality
CONTENT
Page content here
KEYWORDS ON
PAGE
software regulatory,downloads,licensing,fda software 483s,what we do,how you benefit,510 k documentation,ce mark documentation,soup/third party/open source software,software requirements decomposition,software only medical devices,coding standards
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Software Regulatory | softwareregulatory.com Reviews

https://softwareregulatory.com

Software Regulatory focuses on the regulatory aspects of software used in medical devices and in clinical trials.

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1

Software Regulatory

http://www.softwareregulatory.com/License01.htm

Licenses for Downloaded Trial Software. Please use this form for licensing:. Please include a valid email address so we can respond to you.]. License for Simple Encryptor Software. SOP - SW Development Package 01. Other, please describe below.

2

Software Regulatory . Com

http://www.softwareregulatory.com/Download01.htm

Click the button below to download a trial version of Simple Encryptor. Simple Encryptor is an easy way of protecting private information in any of your files. The encryption may not stop a determined professional, but does provide a reasonable level of modern cryptographic security. Because a symmetric key algorithm is used, you must know the key that you used to encrypt a file in order to decrypt it. Simple Encryptor is designed to be fast and easy to use. It works on all types of files. Click the Down...

3

Software Regulatory . Com

http://www.softwareregulatory.com/FDAWarningLetters01.htm

Inspectional Observations for Software. Summary of FDA's Inspectional Observation Data Sets. Based on data provided by FDA at http:/ www.fda.gov/ICECI/Inspections/ucm250720.htm). Based on the most recently available data from FDA. Years are FDA fiscal years. Table 1. Summary of FDA 483 Citations (2006-2014). Number of 483's Issued for all Medical Devices. Table 2. Software-related citations by Search Term. Number of Inspectional Observations (see details in table 3). Design validation - software validati...

4

Software Regulatory

http://www.softwareregulatory.com/index.htm

Prompt, Confidential, Effective. We provide expert advice on regulations and standards that apply to software in medical devices and software used for clinical trials. Done correctly, you'll run more efficiently and get to market faster:. We strive to keep it simple and not fog up your business practices unnecessarily. Where We Can Help. Commercial Off-the-Shelf Software (COTS). Software Testing, Validation and Verification. Embedded Software and Firmware. Preparation for BiMo and ISO audits.

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Prompt, Confidential, Effective. We provide expert advice on regulations and standards that apply to software in medical devices and software used for clinical trials. Done correctly, you'll run more efficiently and get to market faster. Where We Can Help. Commercial Off-the-Shelf Software (COTS). Software Testing, Validation and Verification. Embedded Software and Firmware. Software Requirements Specifications and Architecture. Preparation for BiMo and ISO audits. ISO 14971 Software Risk Management.

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