Donna Philput, Ccra

Donna Philput, Ccra Email and Phone Number

Managing Director at Medical Human Factors (medHF) @ Medical Human Factors (medHF)
sursee, lucerne, switzerland
Donna Philput, Ccra's Location
Westerville, Ohio, United States, United States
Donna Philput, Ccra's Contact Details

Donna Philput, Ccra work email

Donna Philput, Ccra personal email

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About Donna Philput, Ccra

Experience:13 years of experience in the medical device development field with a strong background in human factors research and quality systems management. Currently I specialize in human factors usability research on combination devices. I have varied experience developing, performing and reporting on heuristic, contextual, early evaluative (formative) and validation (summative) human factors studies regarding the usability and safety of medical devices as part of the FDA, EU approval process. This user research is centered on a risk-based approach to device development, and includes a thorough understanding of various ISO, AAMI, EN, and FDA standards and guidelines.

Donna Philput, Ccra's Current Company Details
Medical Human Factors (medHF)

Medical Human Factors (Medhf)

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Managing Director at Medical Human Factors (medHF)
sursee, lucerne, switzerland
Website:
med-hf.com
Employees:
16
Donna Philput, Ccra Work Experience Details
  • Medical Human Factors (Medhf)
    Director
    Medical Human Factors (Medhf) Aug 2019 - Present
    Ohio, United States
  • Medical Human Factors (Medhf)
    Sr. Human Factors Specialist
    Medical Human Factors (Medhf) Oct 2018 - Present
    Columbus, Ohio Area
  • Priority Designs
    Sr. Quality/Regulatory Specialist
    Priority Designs Sep 2016 - Oct 2018
    Columbus, Ohio Area
  • Battelle Memorial Institute
    Quality System Coordinator
    Battelle Memorial Institute Mar 2008 - Jun 2014
    Columbus, Ohio
  • Percuvision Llc
    General Manager
    Percuvision Llc Jun 2007 - Feb 2011
    Created the quality system for design and development of medical device. Set up a feasibility clinical trial with the prototyp product at a local hospital. Prepared for and participated in an FDA audit, managed document control through design and development into production. Developed the infrastructure for customer service/complaints and the logistics for product manufacturing.

Donna Philput, Ccra Skills

Medical Devices Quality System Fda Iso 13485 Design Of Experiments Start Ups Supply Chain Management Human Centered Design User Research Human Subjects Research Product Design Regulatory Compliance Regulatory Requirements Product Lifecycle Management Customer Service Process Improvement

Donna Philput, Ccra Education Details

Frequently Asked Questions about Donna Philput, Ccra

What company does Donna Philput, Ccra work for?

Donna Philput, Ccra works for Medical Human Factors (Medhf)

What is Donna Philput, Ccra's role at the current company?

Donna Philput, Ccra's current role is Managing Director at Medical Human Factors (medHF).

What is Donna Philput, Ccra's email address?

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What is Donna Philput, Ccra's direct phone number?

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What schools did Donna Philput, Ccra attend?

Donna Philput, Ccra attended Ohio University, Ohio University.

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What skills is Donna Philput, Ccra known for?

Donna Philput, Ccra has skills like Medical Devices, Quality System, Fda, Iso 13485, Design Of Experiments, Start Ups, Supply Chain Management, Human Centered Design, User Research, Human Subjects Research, Product Design, Regulatory Compliance.

Who are Donna Philput, Ccra's colleagues?

Donna Philput, Ccra's colleagues are Lee Wood, Dan Evans, Rosalee Meyer, Taylor Reagan, Karen Guerrero , Phd, Moara Marques, Aurélie Pager.

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