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CONTACTS AT MED-VISORY.COM

Med-Visory Consulting

Richard Basler

15412 ●●●●●●Circle

ir●●ne , California, 92604

United States

(949)●●●●●-6989

ra●●●●●●@aol.com

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Med-Visory Consulting

Richard Basler

15412 ●●●●●●Circle

ir●●ne , California, 92604

United States

(949)●●●●●-6989

ra●●●●●●@aol.com

View this contact

Med-Visory Consulting

Richard Basler

15412 ●●●●●●Circle

ir●●ne , California, 92604

United States

(949)●●●●●-6989

ra●●●●●●@aol.com

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med-visory.com

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Med-Visory Consulting

http://www.med-visory.com/software.html

Software has become ubiquitous in today’s medical devices, and with the new, stricter federal guidelines on submissions for devices which include software components, it has become vital for your consultants to have a thorough understanding of software development and their quality systems. At Med-Visory, we have nearly twenty years of experience within the software industry, participating in development projects from the earliest stages of design through to localization, maintenance, and support.

2

Med-Visory Consulting

http://www.med-visory.com/services.html

Complete Quality Systems Manual complying with federal, state, and international requirements. California State medical device licensing. FDA New Product submissions (510k/IDE/PMA). Internal and Vendor audits. Manufacturing and Sterilization systems qualification. Development of quality and regulatory strategies.

3

Med-Visory Consulting

http://www.med-visory.com/development.html

Development of Quality Systems. As Your Quality Consultant, We Will:. Develop an individualized Quality System Manual and procedures meeting FDA and international standards. Provide employee training in quality systems and methodologies. Perform internal and vendor audits. Assist in the development and validation of products, vendors, and manufacturing/sterilization methods. Prepare and conduct periodic management reviews.

4

Med-Visory Consulting

http://www.med-visory.com/about.html

Rich is a Certified Quality Auditor under the American Society for Quality (ASQ). Eric is a Certified Quality Auditor (CQA) under the American Society for Quality (ASQ), and is a Microsoft Certified Systems Engineer.

5

Med-Visory Consulting

http://www.med-visory.com/auditing.html

Quality System and Vendor Auditing. As Your Auditor, We Will:. Perform First- and Second-Party audits of your internal processes or outside vendors. Assist in preparing for upcoming audits from regulatory agencies or notified bodies. Help verify the progress and effectiveness of Quality Management Procedures. Analyze audit findings and assist you in finding the opportunities to further improve your Quality Systems. Prepare and conduct periodic management reviews.

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