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CONTACTS AT QMR-LLC.COM

QMR, LLC

John Hoffman

9922 E. ●●●●●●●●le Drive

Sun●●●kes , AZ, 85248

United States

1.48●●●●4009
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QMR, LLC

John Hoffman

9922 E. ●●●●●●●●le Drive

Sun●●●kes , AZ, 85248

United States

1.48●●●●4009
1.48●●●●4009
jo●●●●●●●●●●@mindspring.com

View this contact

QMR, LLC

John Hoffman

9922 E. ●●●●●●●●le Drive

Sun●●●kes , AZ, 85248

United States

1.48●●●●4009
1.48●●●●4009
jo●●●●●●●●●●@mindspring.com

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1 your subtitle text
2 home page
3 services offered
4 consulting experience
5 professional experience
6 submissions experience
7 mdds
8 guestbook
9 info@qmr llc com
10 fallbrook ca
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1

Ben F. Pepper, Jr.

http://www.qmr-llc.com/Ben_Pepper.html

QMR, LLC - Quality Management Resources. John C. Hoffman. Ben F Pepper, Jr. BEN F PEPPER, Jr. Managing Consultant - Healthcare IT. Experienced IT professional with over 25 years of IT and Compliance experience in a variety of multinational and domestic companies. Expertise in FDA, SEC, PCI and HIPAA regulatory requirements as they apply to IT Governance. Experience supporting startups that are regulated by FDA and SEC. Experience in Medical Device Data Systems (MDDS), Mobile Medical Apps and IEC-80001.

2

MDDS

http://www.qmr-llc.com/MDDS.html

QMR, LLC - Quality Management Resources. John C. Hoffman. Ben F Pepper, Jr. A new classification regulation effective February 2011. 21 CFR 880.6310 - Medical device data system. Initial MDDS registration was required by May 16th,. MDDS will be actively enforced beginning April 18th,. 2012 through on-site FDA inspections. Medical device data is electronic data that originates from a medical device. MDDS reclassifies data systems that electronically:. Transfer, store, convert or display medical device data.

3

Submissions Experience

http://www.qmr-llc.com/Submissions_Experience.html

QMR, LLC - Quality Management Resources. John C. Hoffman. Ben F Pepper, Jr. Johnson and Johnson Sterile Design Division. Approximately fifteen 510(k) submissions for custom sterile procedure packs and cardiopulmonary blood reservoir. White Knight Health Care. Approximately ten 510(k) submissions for custom sterile procedure packs and a variety of sterile and non-sterile reusables and disposables. One 510(k) submission for stand alone blood bank software. Two 510(k) submissions for drugs of abuse test kits.

4

Consulting Experience

http://www.qmr-llc.com/Consulting_Experience.html

QMR, LLC - Quality Management Resources. John C. Hoffman. Ben F Pepper, Jr. QMR, LLC provides Quality Management and Regulatory Consulting Services including for ISO 9000/13485, FDA Compliance Consulting, Product Submissions, FDA 483/Warning Letter Responses, Quality Assurance and Management, Quality Systems Certification, Assessments, Audits, Training and Vendor Sourcing. PatientSafe Solutions, San Diego, CA. Sun Biomedical Laboratories, Blackwood, NJ. MedApps, Scottsdale, AZ. Sage Products, Cary, IL.

5

John C. Hoffman

http://www.qmr-llc.com/John_C.html

QMR, LLC - Quality Management Resources. John C. Hoffman. Ben F Pepper, Jr. JOHN C. HOFFMAN. Creative and responsible professional with extensive worldwide V.P./Director level experience. Expertise in quality assurance and management and medical device regulatory affairs. Other areas of proficiency include all FDA regulations, ISO 9000/13485 international quality. SKILLS and SPECIAL QUALIFICATIONS. Experienced in start-ups and re-engineering quality systems. Twenty years experience in medical software an...

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Orcanos Partners

http://www.orcanos.com/compliance/orcanos-partners

Contact Sales: US 1 760 451 6306 ISRAEL 972 537 2561. Polaris Systems Engineering Co. Ltd has been established on January 1999. The company located in Rehovot Tamar Science Park, Israel, and deals mainly with:. Design and production of ATE (Automated Test Equipment), as turnkey projects for production lines and field echelons, labs and development departments. Development of PCBs and Systems for Real Time; simulation; monitoring and controlling systems. The Orcanos’ QPack solution, together with Te...

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Home Page

QMR, LLC - Quality Management Resources. John C. Hoffman. Ben F Pepper, Jr. FDA REGULATION CONSULTING SERVICES. QMR, LLC provides Quality Management and Regulatory Consulting Services including for ISO 9000/13485, FDA Compliance Consulting, Product Submissions, FDA 483/Warning Letter Responses, Quality Assurance and Management, Quality Systems Certification, Training and Vendor Sourcing. QUALITY MANAGEMENT and ASSURANCE IS KEY. PROVIDE COST EFFECTIVE SERVICES. ARCHITECTS OF QUALITY SYSTEM BASED SOLUTIONS.

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Qualitative Market Research Recruitment. Welcome to QMR Recruitment. We are an independent agency who specialise in the recruitment of respondents for market research projects. Most of our focus groups take place in London and the surrounding areas. Our research methods include:. We are constantly on the look-out for bright, chatty, enthusiastic people to take part in our client’s projects to ensure that our pool of respondents can meet all of our client’s needs and more.

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