Testimonials

%name Testimonials

Below is a collection of testimonials from a few of our clients whom we have provided training and consulting services for over the years. To post a review of Medical Device Academy, please visit our Google Business Profile.

Testimonials

While searching for guidance on how to validate an IFU, I came across the webinar on ‘IFU Validation and PMS’ sponsored by Medical Device Academy. It was very helpful – not only did I get an understanding of validating an IFU but learned more about Post Market Surveillance. I have always found articles by Rob extremely well-written, practical, and always helpful. This webinar was a reasonable cost and the payback was invaluable.

-Barbara Rinaldi, Dir QA, Tepha, Inc

“It was a great opportunity of learning when Mr. Rob Packard was available at our facility and spent 4 days on knowledge transfer. His skill to identify the gap between requirement and practice was admiring. His guidance strengthens the compliance practice. His advice on the effectiveness of corrective action, design control elements and process approach concept added value to our quality system”

–  Abdul Raheem, QA Manager, UNIMED, KSA

“I really enjoyed meeting Rob and taking his 2-day lead auditor course, but the learning didn’t stop when the course was over. When he returned my graded exam he took the time to explain the correct answers to questions I got wrong. Providing the correct answers was very helpful. I wish my previous auditing instructor had done the same.”

–  Tony Sapp, Medical Device Supplier Auditor

“We had our FDA inspection mid last year. Your webinar and prep tips were genuinely useful to me in our preparation activities. The war room was a great success! It was actually my first FDA inspection and a great learning curve for me and our site.”

–  Brian Mulcahy, QA Manager; Ireland

“I conducted a thorough search for a senior consultant to conduct a project which required specialized knowledge of medical devices, ISO 13485, and European directives. Mr. Robert Packard was by far the most qualified among the candidates; he not only met the technical profile but I found his emotional intelligence skills remarkable. In simple terms, Mr. Packard was:
  • Expert in the areas of implantable medical devices, ISO 13485, and CE marking,
  • Methodical in his work,
  • Knowledgeable in the ways of the medical device industry, and
  • Most importantly, he was very easy to work with.

I highly recommend Mr. Packard and vouch for him.”–  Zak Kouloughli, President, Tradeline Medical; Austin, TX“Robert is by far the best quality practitioner and “partner” with whom I’ve worked. He is an expert in Quality Assurance including Regulatory Affairs for ISO 13485 (medical devices). Perhaps Robert’s best attribute however is his ability and eagerness to transfer his knowledge. He has a knack for taking often complex methodologies and breaking them down into simpler terms using examples and analogies so that his audience walks away with a complete understanding of the topic. I’m continually amazed at Robert’s breadth of knowledge and his recall. Robert is highly recommended for training Quality related topics including but certainly not limited to ISO certification, Auditing, Supplier evaluations, CAPA, Root Cause Investigation, and complaint handling. You’ll walk away with a thorough understanding of the topic and thinking about which topic you’d like Robert to present next.”– Alan FrechetteQA Supervisor, PEXCO Medical Products; Athol, MA“Rob Packard has a unique and special ability to train individuals in a manner that not only do they learn, but they have fun doing so! He is able to take a topic that is “boring” and make it interesting.  He has a wealth of product, quality, and auditing knowledge that gives him a balance that I have not seen with any other trainer. I have been in quality for 25 years and have been through several training classes; however, I have never experienced or walked away with as much knowledge as I did with his training class. He is awesome!”– Julee BankesQA Manager, SmartPractice; Phoenix, AZ“One thing is certain with Bob – you will not find anyone more versed, not only in the obvious Regulatory/Audit/Certification area but also in all facets of operations. This is the real reason why his expertise is so valuable. He cannot be fooled and he will talk the talk with the experts at your company with ease and insight. Almost all the “trainers” out there have serious limitations. Not so with Bob.”– Dennis R. CoteSupply Chain Manager, CAS Medical Systems, Inc.; Branford, CT“Rob Packard is an excellent teacher whether it is in a classroom setting, conference room setting, or the shop floor. His detailed recall of the key quality standards in the industry today allows him to provide his students with accurate information that ensures they will always have the correct training to navigate the perils of an external audit from any organization or government body. What makes Rob unique is his ability to show his students or clients how to reduce the details and requirements of the quality standards into a world-class QMS for each of their employers. Each time I interact with Rob, I come away with specific ideas that I implement to improve the quality system and products manufactured by KaZaK.”– Brian J. SmithDirector of Engineering, KaZaK Composites, Inc.; Woburn, MA 

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