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Liam Brady
Technical Operations leader at Insulet Corporation
November 2016
Which certifications do device companies/manufacturers value in their employees?
< 1 min reading time

Thank you for your time and congratulations on your involvement in Medical Devices. I am writing because I am considering a shift in career toward medical device manufacturing. My background is management of high-tech/computer manufacturing and test (at Manufacturing Director level), and I could use some guidance please on where to start, specifically regarding certification/trainings, to help bring meaningful value to manufacturer/employers! I am wondering if, as example, CMDCP certification is worth the cost and time, if recruiters and hiring managers would value it, etc. Similarly for other trainings. I have found many options including the following:
ISO 9001- 13485
FDA CFR Part 820
CMDCP (Certified Manufacturing Device Compliance Professional)
GMPCP (Current Good Manufacturing Certified Professional)
GMP ICH Q7
GAMP (Good Automated Manufacturing Practice).

I would greatly appreciate any advice, please, on how to approach/prioritize this opportunity.
Thank you again,
Liam Brady MBA PMP

source: https://www.linkedin.com/groups/78665/78665-6199656283860193280

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Posted by Liam Brady
Asked on November 2, 2016 12:00 am
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Tarek Elneil The most important one is CFR 21 Part 820. And ISO 13485
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Liam Brady Hello Tarek, Thank you. That's very helpful.
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Rob Packard Certifications are good, but experience is what you need. With regard to the certifications that you listed, they are not all created equal:
ISO 9001 has become a defunct standard, because the 2015 version now deviates significantly from the ISO 13485 standard. Many medical device manufacturers are dropping this certification.
ISO 13485 is critical to the device industry, but make sure you are being trained to the 2016 version. Here's a link if you need training.
FDA CFR Part 820 is critical for US manufacturers and companies that sell in the USA. Here's a link if you need training.
CMDCP (Certified Manufacturing Device Compliance Professional) - this is a new certification that very few companies have heard of.
GMPCP (Current Good Manufacturing Certified Professional) - this is a new certification that very few companies have heard of.
GMP ICH Q7 - this is a risk management guidance for the pharmaceutical industry. Device companies are more interested in ISO 14971. Here's a link
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Julie Omohundro Try searching some the large online job boards for the type of job you are interested in, and see what they are asking for in the way of credentials.
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I agree ISO 13485, 21 CFR Part 820 and training/working knowledge in Risk management and Design controls is a help
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Liam Brady Thank you all for taking the time to respond and for your helpful input.
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Robert Packard, the training links are not appearing. Could you kindly post again?
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Andrew Kyle You might consider becoming a PMP. All business activities are 'projects'. You need to be in control per GMP - managing your department and leading in being a PMP will benefit. The other credentials are less rigorous - you have a complex test to achieve PMP certification.
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Andrew Kyle, you might notice that Liam has PMP certification, as noted in his signature (just after 'MBA')
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Andrew Kyle Smart
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BTW, ISO 9001- 13485 revised this year
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Hi Liam.
As Robert said, experience is highly valuable.
The most important certification to start with is ISO 13485. I suggest to have an ISO 13485 auditor certification.
Then, depending on the medical devices of your interest (implants, electrical, etc.), you can complete your training with courses of the following standards: ISO 14971, IEC 62366, ISO 10993 series, IEC 60601, etc.
Also, it is important to define the markets of your interest since they have particular regulatory requirements.
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Liam Brady Thank you all again for your valuable guidance.

Cynthia, regarding the links that Robert Packard had mentioned, perhaps this will help:
http://medicaldeviceacademy.com/iso-13485-2016-webinars/
http://medicaldeviceacademy.com/21-cfr-820-a-roadmap-to-fda-compliance/
http://medicaldeviceacademy.com/implementing-risk-management-process-compliant-iso-149712007-address-seven-deviations-identified-en-iso-149712012/

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A combination of experience and APICS certifications can help. For finance personnel, I would recommend a CPA, CMA certification.
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