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Risk Management Needs Assessment Survey

Needs assessment survey for Personalized Risk Management Coaching. 

Please complete this brief survey to help us deliver the best coaching experience for you. 

Start

Client Information

General information about you, your industry/product, your role and functional area, and your current objectives

Question 2 of 19

Your Name

Question 3 of 19

Your Title

Question 4 of 19

Company Name

Question 5 of 19

Product Type (Select the category directly applicable to your current role)

A

Medical Devices

B

In-vitro Diagnostics (IVD)

C

Combination Products

D

Other - non Medical

Question 6 of 19

Medical Specialty Focus (Select the category directly applicable to your current role)

A

Orthopedic

B

Cardiovascular

C

Ophthalmic

D

Radiology

E

ENT - Ear, Nose, and Throat

F

Gastroenterology (GI) and Urology

G

Dental

H

General Hospital

I

Other - Not Listed Here

Question 7 of 19

What is the primary market for your product(s)? 

A

North America

B

European Union, United Kingdom, Ireland

C

Japan

D

BRIC - Brazil, Russia, India, China

E

Eastern Europe, Middle East and Asia

F

Latin America, South America

G

Australia, New Zealand

Question 8 of 19

Your Functional Area

A

General Quality Assurance or Quality Engineering

B

General Risk Management

C

Design and Development

D

Complaints/Post-Market Surveillance

E

Product Quality

F

Medical or Clinical

G

Regulatory Affairs

H

Audits/Regulatory Compliance

I

Other - Not Listed Here

Question 9 of 19

How would you best characterize your current objective?

A

To improve my personal knowledge and ability to develop and/or implement a compliant process

B

To ensure regulatory compliance (EU-MDR, ISO 14971 etc.)

C

To streamline our process for better efficiency

D

To help accelerate new product development and innovation

E

Other - Please describe in the next question

Question 10 of 19

Please provide additional details about your current objective(s) 

Current Challenges

Specific details of your current challenge(s) you would like to discuss during our coaching sessions

Question 12 of 19

Current challenge(s) you are hoping to address through coaching

(Select all that apply)
A

General understanding of risk management requirements per ISO 14971

B

Overall Risk Management Process/Procedure/Policy

C

Integrating Risk Management and Design Control

D

Post-Market Surveillance and Risk Update

E

Applying a risk-based approach to Quality Management System requirements

F

Risk Management Plan

G

Hazard Analysis (harms, hazards, hazardous situations)

H

Risk Analysis (FMEA, FTA or other methods and how to link them to hazard anaysis)

I

Risk Evaluation, Benefit-Risk

J

Risk Management Report

K

Other - Not Listed Here (Please provide details in the next question)

Question 13 of 19

Please provide additional details about your current challenge(s) you are hoping to address through coaching.

Priorities and Expectations

Please describe your highest priority and expectations from our first coaching session. 

Question 15 of 19

Please outline your highest priority items for our first coaching session (Note: the more specific you are, the better would be the outcome!)

Question 16 of 19

Describe what other approaches you have tried in the past to address the highest priority item(s) you would like to discuss in our first coaching session.

Question 17 of 19

What is working well for you in your current process related to these high priority items?

Question 18 of 19

What are the most critical gaps in your process related to these high priority items? 

Question 19 of 19

Any other information or special request(s) you would like to share with us

Confirm and Submit