Regulatory Open Forum

Good afternoon,

Can anyone recommend the best way to study for the RAC Devices Exam?

What are the best resources to utilize? Do you find study groups to be beneficial?

Please let me know at your earliest convenience.

Best regards,
Eric

------------------------------
Eric Dengelegi
Regulatory Affairs Specialist
------------------------------

Hello Eric,

I used the Fundamentals books from RAPS, studied the book, looked through many of the regulations, and also took some of the practice exam to get a feel for how the questions are written.  I did not participate in a study group, but self-study, though study groups are always nice to share materials, share thoughts, and go through the practice questions together.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 13-Sep-2021 14:07
From: Eric Dengelegi
Subject: Studying for RAC Devices Exam

Good afternoon,

Can anyone recommend the best way to study for the RAC Devices Exam?

What are the best resources to utilize? Do you find study groups to be beneficial?

Please let me know at your earliest convenience.

Best regards,
Eric

------------------------------
Eric Dengelegi
Regulatory Affairs Specialist
------------------------------

Hello Richard,

How can we get some practice exams?

Thanks,





------------------------------
Ana Alvarez
Regulatory Affairs Lead, EMEA
ZUG
Switzerland
------------------------------

Original Message:
Sent: 14-Sep-2021 02:37
From: Richard Vincins
Subject: Studying for RAC Devices Exam

Hello Eric,

I used the Fundamentals books from RAPS, studied the book, looked through many of the regulations, and also took some of the practice exam to get a feel for how the questions are written.  I did not participate in a study group, but self-study, though study groups are always nice to share materials, share thoughts, and go through the practice questions together.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 13-Sep-2021 14:07
From: Eric Dengelegi
Subject: Studying for RAC Devices Exam

Good afternoon,

Can anyone recommend the best way to study for the RAC Devices Exam?

What are the best resources to utilize? Do you find study groups to be beneficial?

Please let me know at your earliest convenience.

Best regards,
Eric

------------------------------
Eric Dengelegi
Regulatory Affairs Specialist
------------------------------

Hello Ana,

These can be obtained through RAPS themselves.  Also some of the study groups people may have access to practice exams.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 14-Sep-2021 03:57
From: Ana Alvarez
Subject: Studying for RAC Devices Exam

Hello Richard,

How can we get some practice exams?

Thanks,





------------------------------
Ana Alvarez
Regulatory Affairs Lead, EMEA
ZUG
Switzerland

Original Message:
Sent: 14-Sep-2021 02:37
From: Richard Vincins
Subject: Studying for RAC Devices Exam

Hello Eric,

I used the Fundamentals books from RAPS, studied the book, looked through many of the regulations, and also took some of the practice exam to get a feel for how the questions are written.  I did not participate in a study group, but self-study, though study groups are always nice to share materials, share thoughts, and go through the practice questions together.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 13-Sep-2021 14:07
From: Eric Dengelegi
Subject: Studying for RAC Devices Exam

Good afternoon,

Can anyone recommend the best way to study for the RAC Devices Exam?

What are the best resources to utilize? Do you find study groups to be beneficial?

Please let me know at your earliest convenience.

Best regards,
Eric

------------------------------
Eric Dengelegi
Regulatory Affairs Specialist
------------------------------

I recommend everything Richard has said. Go through the books a few times, a few chapters a week or one chapter per day. Make notes in the margins and underline anything you don't understand or want to remember so you can research it futher.

It helps to make flashcards based on the books and on questions you got wrong on initial practice exams. (Take the practice exam often if you have regular access to it.) Have your spouse/s.o., family member, or a friend quiz you on the flashcards twice a day. (Having another person quizzing you keeps you honest; you can't say to yourself "Oh, I basically got that last one right...").

If you get an answer wrong (or even "half-right") put that card into a "Don't Know" pile and study it again at the next flashcard session later in the day. If you get it right, put it in the "I Know It" pile, but review it every few sessions.

Good luck!

------------------------------
Ian Broome, M.S. RAC
Needham, MA
United States
------------------------------

Original Message:
Sent: 15-Sep-2021 03:08
From: Richard Vincins
Subject: Studying for RAC Devices Exam

Hello Ana,

These can be obtained through RAPS themselves.  Also some of the study groups people may have access to practice exams.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Sep-2021 03:57
From: Ana Alvarez
Subject: Studying for RAC Devices Exam

Hello Richard,

How can we get some practice exams?

Thanks,





------------------------------
Ana Alvarez
Regulatory Affairs Lead, EMEA
ZUG
Switzerland

Original Message:
Sent: 14-Sep-2021 02:37
From: Richard Vincins
Subject: Studying for RAC Devices Exam

Hello Eric,

I used the Fundamentals books from RAPS, studied the book, looked through many of the regulations, and also took some of the practice exam to get a feel for how the questions are written.  I did not participate in a study group, but self-study, though study groups are always nice to share materials, share thoughts, and go through the practice questions together.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 13-Sep-2021 14:07
From: Eric Dengelegi
Subject: Studying for RAC Devices Exam

Good afternoon,

Can anyone recommend the best way to study for the RAC Devices Exam?

What are the best resources to utilize? Do you find study groups to be beneficial?

Please let me know at your earliest convenience.

Best regards,
Eric

------------------------------
Eric Dengelegi
Regulatory Affairs Specialist
------------------------------

Ian,

Thank you for the suggestions - greatly appreciated.

------------------------------
Eric Dengelegi
Regulatory Affairs Specialist
Malvern PA
United StatesEricDengelegiRegulatory Affairs Specialist
------------------------------

Original Message:
Sent: 15-Sep-2021 17:44
From: Ian Broome
Subject: Studying for RAC Devices Exam

I recommend everything Richard has said. Go through the books a few times, a few chapters a week or one chapter per day. Make notes in the margins and underline anything you don't understand or want to remember so you can research it futher.

It helps to make flashcards based on the books and on questions you got wrong on initial practice exams. (Take the practice exam often if you have regular access to it.) Have your spouse/s.o., family member, or a friend quiz you on the flashcards twice a day. (Having another person quizzing you keeps you honest; you can't say to yourself "Oh, I basically got that last one right...").

If you get an answer wrong (or even "half-right") put that card into a "Don't Know" pile and study it again at the next flashcard session later in the day. If you get it right, put it in the "I Know It" pile, but review it every few sessions.

Good luck!

------------------------------
Ian Broome, M.S. RAC
Needham, MA
United States

Original Message:
Sent: 15-Sep-2021 03:08
From: Richard Vincins
Subject: Studying for RAC Devices Exam

Hello Ana,

These can be obtained through RAPS themselves.  Also some of the study groups people may have access to practice exams.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 14-Sep-2021 03:57
From: Ana Alvarez
Subject: Studying for RAC Devices Exam

Hello Richard,

How can we get some practice exams?

Thanks,





------------------------------
Ana Alvarez
Regulatory Affairs Lead, EMEA
ZUG
Switzerland

Original Message:
Sent: 14-Sep-2021 02:37
From: Richard Vincins
Subject: Studying for RAC Devices Exam

Hello Eric,

I used the Fundamentals books from RAPS, studied the book, looked through many of the regulations, and also took some of the practice exam to get a feel for how the questions are written.  I did not participate in a study group, but self-study, though study groups are always nice to share materials, share thoughts, and go through the practice questions together.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 13-Sep-2021 14:07
From: Eric Dengelegi
Subject: Studying for RAC Devices Exam

Good afternoon,

Can anyone recommend the best way to study for the RAC Devices Exam?

What are the best resources to utilize? Do you find study groups to be beneficial?

Please let me know at your earliest convenience.

Best regards,
Eric

------------------------------
Eric Dengelegi
Regulatory Affairs Specialist
------------------------------

I agree all of the above.  Also focus on areas where you may have less experience with.  If you have never done a 510k before or participated in any post-market compliance activities, I suggest spending more time reading up on those regulatory requirements.  Self-study is fine. Try to get a practice exam to see how you do.

------------------------------
Karen Zhou
------------------------------

Original Message:
Sent: 13-Sep-2021 14:07
From: Eric Dengelegi
Subject: Studying for RAC Devices Exam

Good afternoon,

Can anyone recommend the best way to study for the RAC Devices Exam?

What are the best resources to utilize? Do you find study groups to be beneficial?

Please let me know at your earliest convenience.

Best regards,
Eric

------------------------------
Eric Dengelegi
Regulatory Affairs Specialist
------------------------------

This message was posted by a user wishing to remain anonymous

Still waiting for results, so I'll stay anonymous in case it turned out I didn't pass... :) :)

I found my study group to be the best part of the exam.  I met people from all over the world and their level of expertise was awesome.

The practice exams had a fair number of "scenario" questions, like "In Situation X, what should an RA professional do?"  There were many such questions where, at my company, the answer would be "A, B, or in certain situations C," but the answer that the exam writer expected was A.  So I found it helpful to have people from a wide variety of backgrounds to discuss these questions with, and help me understand the exam writer's thinking.

Similarly when going through e.g. practice exams, if you have people who are experts in compliance, premarket, EU, whatever, and you don't know something, they can quickly bring you up to speed in the relevant area.  Like (just an example) let's say a question has to do with abbreviated vs. special vs. traditional 510(k)'s.  If I'm on my own and my specialty is EU, I have to spend a lot of time looking up what the right answer is and why I got the question wrong.

If I have a US premarket expert, that person can instantly explain and probably point me to the right guidance.

So it was good to be part of a study group because for me some things were just book knowledge, but other people in the group actually worked with them and could put them in broader contexts.  It was also humbling to learn how much about RA I didn't know!
Original Message:
Sent: 13-Sep-2021 14:07
From: Eric Dengelegi
Subject: Studying for RAC Devices Exam

Good afternoon,

Can anyone recommend the best way to study for the RAC Devices Exam?

What are the best resources to utilize? Do you find study groups to be beneficial?

Please let me know at your earliest convenience.

Best regards,
Eric

------------------------------
Eric Dengelegi
Regulatory Affairs Specialist
------------------------------

Hi Eric,
I signed up for the RAC-Devices Exam this Fall (2021). If interested, we can form a study group or join one, if there is already one.

Raghu

------------------------------
Raghu Jainapur
Plymouth MN
United States
------------------------------

Original Message:
Sent: 13-Sep-2021 14:07
From: Eric Dengelegi
Subject: Studying for RAC Devices Exam

Good afternoon,

Can anyone recommend the best way to study for the RAC Devices Exam?

What are the best resources to utilize? Do you find study groups to be beneficial?

Please let me know at your earliest convenience.

Best regards,
Eric

------------------------------
Eric Dengelegi
Regulatory Affairs Specialist
------------------------------

Original Message:
Sent: 9/17/2021 5:04:00 PM
From: Raghu Jainapur
Subject: RE: Studying for RAC Devices Exam

Hi Eric,
I signed up for the RAC-Devices Exam this Fall (2021). If interested, we can form a study group or join one, if there is already one.

Raghu

------------------------------
Raghu Jainapur
Plymouth MN
United States
------------------------------

Original Message:
Sent: 13-Sep-2021 14:07
From: Eric Dengelegi
Subject: Studying for RAC Devices Exam

Good afternoon,

Can anyone recommend the best way to study for the RAC Devices Exam?

What are the best resources to utilize? Do you find study groups to be beneficial?

Please let me know at your earliest convenience.

Best regards,
Eric

------------------------------
Eric Dengelegi
Regulatory Affairs Specialist
------------------------------