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FDA Approval of Medical and Diagnostic Devices: New World Regulatory Solutions

NWRS' expertise encompasses FDA pre-market notifications including protocol development, Investigational Device Exemptions (IDE), 510(k) submissions and premarket applications (PMA), CLIA waiver petitions, quality system management for cGMP compliance, CE marking and ISO certification, risk management, labeling and advertising, complaint handling, post marketing surveillance, recalls, vigilance and adverse event reporting, product and establishment registrations and laboratory studies.

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FDA Approval of Medical and Diagnostic Devices: New World Regulatory Solutions | newworldreg.com Reviews

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NWRS' expertise encompasses FDA pre-market notifications including protocol development, Investigational Device Exemptions (IDE), 510(k) submissions and premarket applications (PMA), CLIA waiver petitions, quality system management for cGMP compliance, CE marking and ISO certification, risk management, labeling and advertising, complaint handling, post marketing surveillance, recalls, vigilance and adverse event reporting, product and establishment registrations and laboratory studies.

<META> KEYWORDS

1 protocol development

2 Investigational Device Exemptions

3 IDE

4 510(k)

5 premarket applications

6 PMA)

7 CLIA waiver

8 quality system management

9 cGMP compliance

10 CE marking

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FDA Approval of Medical and Diagnostic Devices: New World Regulatory Solutions | newworldreg.com Reviews

https://newworldreg.com

NWRS' expertise encompasses FDA pre-market notifications including protocol development, Investigational Device Exemptions (IDE), 510(k) submissions and premarket applications (PMA), CLIA waiver petitions, quality system management for cGMP compliance, CE marking and ISO certification, risk management, labeling and advertising, complaint handling, post marketing surveillance, recalls, vigilance and adverse event reporting, product and establishment registrations and laboratory studies.

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newworldreg.com

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Providing FDA Approval of Medical and Diagnostic Devices: New World Regulatory Solutions

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There are many aspects to successful market entrance for new diagnostic tests? Any device that successfully passes through the US FDA pre-market review was designed to meet that goal. Whether your test design meets FDA clearance criteria before or after your initial submission is up to you. Strategic Planning from Concept to Market. Premarket Notification 510(k) Submissions. Premarket Approval Applications (PMA). Training, Monitoring and Close Out. From advice to complete turn key services. Planning for ...

2

FDA Approval of Medical and Diagnostic Devices: New World Regulatory Solutions

http://www.newworldreg.com/index.html

New World Regulatory Solutions (NWRS) has seasoned professionals with decades of combined experience in regulatory, clinical, quality and technical affairs in the medical device and in vitro. Maureen Garner, MS, MT (ASCP), ASQ CQA, President. Glenn Neuman, MS, Director of Scientific Affairs. Suzan Fenichel, MT (ASCP), Manager, Regulatory/Clinical. Katrina Fiedler, BS, ASQ CQA, RAPS RAC-US, Director, Quality System/Compliance. Maureen, Glenn and Katrina are active members of the Regulatory Affairs Profess...

3

CLIA waiver process and success with New World Regulatory Solutions

http://www.newworldreg.com/NWRSandCLIA.html

NWRS and CLIA WAIVERS. We specialize in CLIA waivers. NWRS experience with the FDA and the CLIA waiver process has resulted in a proven record of success in obtaining CLIA waivers for our clients. New World Regulatory Solutions will:. Interact with the FDA. Recommend device design that meets CLIA waiver requirements. Create specialized labeling that meets CLIA requirements. Develop protocols for CLIA waiver studies. Negotiate FDA agreement on study design and protocols. Address and solve FDA concerns.

4

Achieving FDA Regulatory Clearances for Domestic and Global Companies: New World Regulatory Solutions

http://www.newworldreg.com/FDARegulatory.html

Progressive partners in achieving FDA regulatory clearances for domestic and global companies. Specializing in Diagnostic Devices:. Strategic Approaches to Compliance. 510(k) and PMA Submissions.

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FDA Approval of Medical and Diagnostic Devices News and Information: New World Regulatory Solutions

http://www.newworldreg.com/News.html

How to Manage Regulatory Issues and get FDA Approvals, Feb 2010. Strengthening the 510(k) Review Process, Feb 2010. FDA Raises the Bar: The Effects of Changes in the 510(k) Programme. Published in Clinica Medtech Intelligence. Issue 1361, March 2010. Clinica is a comprehensive business information service serving the worldwide medical technology industry. Making a Comeback After a Negative US FDA Experience. This article was first published Clinica Medtech Intelligence.

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New World Regulatory Solutions (NWRS) has seasoned professionals with decades of combined experience in regulatory, clinical, quality and technical affairs in the medical device and in vitro. Maureen Garner, MS, MT (ASCP), ASQ CQA, President. Glenn Neuman, MS, Director of Scientific Affairs. Suzan Fenichel, MT (ASCP), Manager, Regulatory/Clinical. Katrina Fiedler, BS, ASQ CQA, RAPS RAC-US, Director, Quality System/Compliance. Maureen, Glenn and Katrina are active members of the Regulatory Affairs Profess...

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