madanielandassociates.com

Daniel & Daniel Consulting

Margin: 0; /* it's good practice to zero the margin and padding of the body element to account for differing browser defaults */ padding: 0;. Daniel and Daniel Consulting has been helping small to medium size medical device companies develop clinical and regulatory strategy, complete clinical studies, gain FDA product clearance / approval and apply the European CE Mark. Obtained new 785nm diagnostic Laser 510(k) clearance from FDA. Obtained FDA PMA approval for Vascular Closure Device.

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Daniel & Daniel Consulting | madanielandassociates.com Reviews

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Margin: 0; /* it's good practice to zero the margin and padding of the body element to account for differing browser defaults */ padding: 0;. Daniel and Daniel Consulting has been helping small to medium size medical device companies develop clinical and regulatory strategy, complete clinical studies, gain FDA product clearance / approval and apply the European CE Mark. Obtained new 785nm diagnostic Laser 510(k) clearance from FDA. Obtained FDA PMA approval for Vascular Closure Device.

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3 about us

4 associates

5 clinical affairs

6 regulatory affairs

7 quality systems

8 links

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Daniel & Daniel Consulting | madanielandassociates.com Reviews

https://madanielandassociates.com

Margin: 0; /* it's good practice to zero the margin and padding of the body element to account for differing browser defaults */ padding: 0;. Daniel and Daniel Consulting has been helping small to medium size medical device companies develop clinical and regulatory strategy, complete clinical studies, gain FDA product clearance / approval and apply the European CE Mark. Obtained new 785nm diagnostic Laser 510(k) clearance from FDA. Obtained FDA PMA approval for Vascular Closure Device.

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madanielandassociates.com

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Regulatory Affairs

http://www.madanielandassociates.com/regulatory.htm

We have extensive hands-on experience managing the regulatory process in partnership with the U.S. FDA, European Notified Bodies and Competent Authorities / Ministries of Health, Canadian Department of Health and Japanese in-country care-takers. Indications for Use negotiation. IDE, PMA, 510(k) submission preparation. 513(g) requests for product classification. Agency request for additional information.

3

Clinical Affairs

http://www.madanielandassociates.com/clinical.htm

We have extensive hands-on experience managing the clinical study process. The following activities are driven by regulatory and marketing strategy requirements:. Protocol and Case Report Form (CRF) development. IDE Preparation and Submission. IRB and Ethics Committee submissions. Site evaluation / qualification. Trial initiation and monitoring. Study management and coordination. Electronic Data Capture (EDC) Systems. Interim and final study reporting.

4

Quality Systems

http://www.madanielandassociates.com/quality.htm

Daniel and Daniel Consulting has designed, developed, implemented and evaluated the compliance of quality systems for over twenty medical device companies. We have excellent templates for simple,. Compliant and effective quality systems. That have been refined over. Multiple years of use.

5

Associates

http://www.madanielandassociates.com/p_and_a.htm

Michael A. Daniel. Ping-Yu Liu, Ph.D. Regulatory / Clinical Affairs/ Strategy. Regulatory, Clinical and Quality Systems, FDA / EU Compliance. Statistics, clinical study design. Regulatory submissions, FDA and EU Compliance, Quality Systems. Mexican / OUS study design and management.

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