Regulatory Open Forum

Hi folks,

I want to take a certificate program to gain more knowledge on Medical device submission processes and requirements in the U.S

Has anyone taken the Medical Device Certificate program offered by RAPS before? Needed some feedback.

What other programs would you recommend to gain knowledge in U.S regulations for Medical devices?

Below are the other courses I found. Any feedback on these?

http://extension.berkeley.edu/public/category/courseCategoryCertificateProfile.do?method=load&certificateId=17180

http://www.ucsc-extension.edu/programs/medical-devices-certificate

http://www.ucsc-extension.edu/programs/regulatory-affairs

I worked for over 4 years as RA specialist(medical device) in Singapore and need to get up to speed on the regulations in the U.S 

Thanks and regards,

Pooja

As part of Northeastern's Graduate Programs in Regulatory Affairs I would certainly recommend you take a look at the Certificate in Medical Device Regulatory Affairs-Please feel free to reach out to me if you would like to discuss further-

Steve Amato

s.amato@neu.edu

Hi folks,

I want to take a certificate program to gain more knowledge on Medical device submission processes and requirements in the U.S

Has anyone taken the Medical Device Certificate program offered by RAPS before? Needed some feedback.

What other programs would you recommend to gain knowledge in U.S regulations for Medical devices?

Below are the other courses I found. Any feedback on these?

http://extension.berkeley.edu/public/category/courseCategoryCertificateProfile.do?method=load&certificateId=17180

http://www.ucsc-extension.edu/programs/medical-devices-certificate

http://www.ucsc-extension.edu/programs/regulatory-affairs

I worked for over 4 years as RA specialist(medical device) in Singapore and need to get up to speed on the regulations in the U.S 

Thanks and regards,

Pooja

Hi, Pooja,

I started with the RAPS Medical Device Certificate program and then went on to earn my RAC (US). 

If you are looking for a certificate for employment qualifications the RAPS certificate program is a good door opener.

If you are looking to learn US medical device regulatory material you have two good on-line options.  One is to take some of the RAPS medical device courses.  Then you have the option to continue towards you certificate and later consider studying for the RAC (US or Global).

A good source of information for medical device training is the FDA.  CDRH Learn has beginner to intermediate web accessed courses that cover both quality and regulatory topics.  They are free and after taking a short quiz you can print a completion certificate.

CDRH Learn

They also have courses in Chinese and Spanish for those interested.

Regards,

Hi folks,

I want to take a certificate program to gain more knowledge on Medical device submission processes and requirements in the U.S

Has anyone taken the Medical Device Certificate program offered by RAPS before? Needed some feedback.

What other programs would you recommend to gain knowledge in U.S regulations for Medical devices?

Below are the other courses I found. Any feedback on these?

http://extension.berkeley.edu/public/category/courseCategoryCertificateProfile.do?method=load&certificateId=17180

http://www.ucsc-extension.edu/programs/medical-devices-certificate

http://www.ucsc-extension.edu/programs/regulatory-affairs

I worked for over 4 years as RA specialist(medical device) in Singapore and need to get up to speed on the regulations in the U.S 

Thanks and regards,

Pooja

Hi folks,

I want to take a certificate program to gain more knowledge on Medical device submission processes and requirements in the U.S

Has anyone taken the Medical Device Certificate program offered by RAPS before? Needed some feedback.

What other programs would you recommend to gain knowledge in U.S regulations for Medical devices?

Below are the other courses I found. Any feedback on these?

http://extension.berkeley.edu/public/category/courseCategoryCertificateProfile.do?method=load&certificateId=17180

http://www.ucsc-extension.edu/programs/medical-devices-certificate

http://www.ucsc-extension.edu/programs/regulatory-affairs

I worked for over 4 years as RA specialist(medical device) in Singapore and need to get up to speed on the regulations in the U.S 

Thanks and regards,

Pooja

Pooha:

In your area, the University of California - Santa Cruz, has an excellent Medical Device Submissions Certification program.  It's based in Santa Clara, not Santa Cruz, so it's close to Foster City.

Like Mark, I'm biased about the program, because I'm an instructor for the Medical Devices Submissions course.  Mine is the only course in the nation that requires that all students to complete an entire mock 510(k) on their own.  I has proven to be a powerful piece of evidence of your capabilities for potential employers.  Many of my students have gone on to get jobs in regulatory, some even when they are in the midst of my 8 wk course.

Naturally there are other courses that are necessary to complete the Certification, but you'll find them all very helpful.

Hi folks,

I want to take a certificate program to gain more knowledge on Medical device submission processes and requirements in the U.S

Has anyone taken the Medical Device Certificate program offered by RAPS before? Needed some feedback.

What other programs would you recommend to gain knowledge in U.S regulations for Medical devices?

Below are the other courses I found. Any feedback on these?

http://extension.berkeley.edu/public/category/courseCategoryCertificateProfile.do?method=load&certificateId=17180

http://www.ucsc-extension.edu/programs/medical-devices-certificate

http://www.ucsc-extension.edu/programs/regulatory-affairs

I worked for over 4 years as RA specialist(medical device) in Singapore and need to get up to speed on the regulations in the U.S 

Thanks and regards,

Pooja

Hi Pooja,

Here is something to consider when choosing between on line and in-person programs. On-line programs are valuable and allow more flexibility in scheduling. However, in-person programs allow for building personal connections with people in the local industry. They also allow for exchanges of skill and experience. 

I chose the UCSC extension program for exactly this reason. The coursework is strong, and the people I met are now colleagues and friends. If you are new to the region, I'd suggest in person coursework, whether you pursue a full certificate or not. 

There was an additional advantage to in-person coursework. I had the chance to see where I had particular strengths and skills relative to my classmates (and vice versa.) Working with a group of classmates allows you to see what you do best as well as what you want to do most. That helps you focus your search on mutually rewarding opportunities.

If you get the chance, take Craig's course - writing a 510(k) in 8 weeks, starting from scratch, gives you work product to show potential employers and is also a huge confidence builder.

Good luck!

Pooha:

In your area, the University of California - Santa Cruz, has an excellent Medical Device Submissions Certification program.  It's based in Santa Clara, not Santa Cruz, so it's close to Foster City.

Like Mark, I'm biased about the program, because I'm an instructor for the Medical Devices Submissions course.  Mine is the only course in the nation that requires that all students to complete an entire mock 510(k) on their own.  I has proven to be a powerful piece of evidence of your capabilities for potential employers.  Many of my students have gone on to get jobs in regulatory, some even when they are in the midst of my 8 wk course.

Naturally there are other courses that are necessary to complete the Certification, but you'll find them all very helpful.

Hi folks,

I want to take a certificate program to gain more knowledge on Medical device submission processes and requirements in the U.S

Has anyone taken the Medical Device Certificate program offered by RAPS before? Needed some feedback.

What other programs would you recommend to gain knowledge in U.S regulations for Medical devices?

Below are the other courses I found. Any feedback on these?

http://extension.berkeley.edu/public/category/courseCategoryCertificateProfile.do?method=load&certificateId=17180

http://www.ucsc-extension.edu/programs/medical-devices-certificate

http://www.ucsc-extension.edu/programs/regulatory-affairs

I worked for over 4 years as RA specialist(medical device) in Singapore and need to get up to speed on the regulations in the U.S 

Thanks and regards,

Pooja

Hi Pooja,

Here is something to consider when choosing between on line and in-person programs. On-line programs are valuable and allow more flexibility in scheduling. However, in-person programs allow for building personal connections with people in the local industry. They also allow for exchanges of skill and experience. 

I chose the UCSC extension program for exactly this reason. The coursework is strong, and the people I met are now colleagues and friends. If you are new to the region, I'd suggest in person coursework, whether you pursue a full certificate or not. 

There was an additional advantage to in-person coursework. I had the chance to see where I had particular strengths and skills relative to my classmates (and vice versa.) Working with a group of classmates allows you to see what you do best as well as what you want to do most. That helps you focus your search on mutually rewarding opportunities.

If you get the chance, take Craig's course - writing a 510(k) in 8 weeks, starting from scratch, gives you work product to show potential employers and is also a huge confidence builder.

Good luck!

Pooha:

In your area, the University of California - Santa Cruz, has an excellent Medical Device Submissions Certification program.  It's based in Santa Clara, not Santa Cruz, so it's close to Foster City.

Like Mark, I'm biased about the program, because I'm an instructor for the Medical Devices Submissions course.  Mine is the only course in the nation that requires that all students to complete an entire mock 510(k) on their own.  I has proven to be a powerful piece of evidence of your capabilities for potential employers.  Many of my students have gone on to get jobs in regulatory, some even when they are in the midst of my 8 wk course.

Naturally there are other courses that are necessary to complete the Certification, but you'll find them all very helpful.

Hi folks,

I want to take a certificate program to gain more knowledge on Medical device submission processes and requirements in the U.S

Has anyone taken the Medical Device Certificate program offered by RAPS before? Needed some feedback.

What other programs would you recommend to gain knowledge in U.S regulations for Medical devices?

Below are the other courses I found. Any feedback on these?

http://extension.berkeley.edu/public/category/courseCategoryCertificateProfile.do?method=load&certificateId=17180

http://www.ucsc-extension.edu/programs/medical-devices-certificate

http://www.ucsc-extension.edu/programs/regulatory-affairs

I worked for over 4 years as RA specialist(medical device) in Singapore and need to get up to speed on the regulations in the U.S 

Thanks and regards,

Pooja

I agree with Joanne. I understand being very busy and  finding it difficult to physically go to classes; but, I found regular in-person meetings to be very valuable to my career. More than 7 years after the program, I am still in regular contact with some of my classmates. Also, I landed a great job through the in-person classes. One of my instructors was impressed with me and recommended me for a job with his company, which I got. 

My opinion is that in-person is the best way to go.

Hi Pooja,

Here is something to consider when choosing between on line and in-person programs. On-line programs are valuable and allow more flexibility in scheduling. However, in-person programs allow for building personal connections with people in the local industry. They also allow for exchanges of skill and experience. 

I chose the UCSC extension program for exactly this reason. The coursework is strong, and the people I met are now colleagues and friends. If you are new to the region, I'd suggest in person coursework, whether you pursue a full certificate or not. 

There was an additional advantage to in-person coursework. I had the chance to see where I had particular strengths and skills relative to my classmates (and vice versa.) Working with a group of classmates allows you to see what you do best as well as what you want to do most. That helps you focus your search on mutually rewarding opportunities.

If you get the chance, take Craig's course - writing a 510(k) in 8 weeks, starting from scratch, gives you work product to show potential employers and is also a huge confidence builder.

Good luck!

Pooha:

In your area, the University of California - Santa Cruz, has an excellent Medical Device Submissions Certification program.  It's based in Santa Clara, not Santa Cruz, so it's close to Foster City.

Like Mark, I'm biased about the program, because I'm an instructor for the Medical Devices Submissions course.  Mine is the only course in the nation that requires that all students to complete an entire mock 510(k) on their own.  I has proven to be a powerful piece of evidence of your capabilities for potential employers.  Many of my students have gone on to get jobs in regulatory, some even when they are in the midst of my 8 wk course.

Naturally there are other courses that are necessary to complete the Certification, but you'll find them all very helpful.

Hi folks,

I want to take a certificate program to gain more knowledge on Medical device submission processes and requirements in the U.S

Has anyone taken the Medical Device Certificate program offered by RAPS before? Needed some feedback.

What other programs would you recommend to gain knowledge in U.S regulations for Medical devices?

Below are the other courses I found. Any feedback on these?

http://extension.berkeley.edu/public/category/courseCategoryCertificateProfile.do?method=load&certificateId=17180

http://www.ucsc-extension.edu/programs/medical-devices-certificate

http://www.ucsc-extension.edu/programs/regulatory-affairs

I worked for over 4 years as RA specialist(medical device) in Singapore and need to get up to speed on the regulations in the U.S 

Thanks and regards,

Pooja