Independent Reviewer

Ready for some nitty-gritty? Let’s see what the FDA has to say about design review (820.30(e)):

“Each manufacturer shall establish and maintain procedures to ensure that formal documented reviews of the design results are planned and conducted at appropriate stages of the device’s design development. The procedures shall ensure that participants at each design review include representatives of all functions concerned with the design stage being reviewed and an individual(s) who does not have direct responsibility for the design stage being reviewed, as well as any specialists needed. The results of a design review, including identification of the design, the date, and the individual(s) performing the review, shall be documented in the design history file (the DHF).”

So, if you need an experienced expert to help you satisfy this requirement, please remember that we’re here to help. But why stop there? We are also available to serve you needs for your other critical reviews including:

Design Reviews
Document Reviews
Process Reviews
Risk Management Reviews
Development Plan Reviews
Project Plan Reviews
Labeling Reviews

It’s nice to know that help is just a phone call away, isn’t it?

“Big efforts,” “worldwide” and “talent” are the firsts words that come to my mind to describe John’s incredible way to reach goals. SpectraMedEx has helped Bioscience handle multiple projects, increasing dramatically our productivity. John’s company is the best partner for our regulatory worldwide projects.

Claudio Bedoya

CEO / BioScience, S.R.L.

John is truly an extraordinary person with great intellect, energy and integrity. His background with a variety of medical device companies has been invaluable to Biomedical Devices of Kansas, llc. John has made has made a real difference in the ability of our Company to effectively manage regulatory and quality systems, as well as product and market development efforts. Medical device companies can have my utmost assurance that John will bring his vast repertoire of skills to each and every client. John will treat you ethically and with respect. Based on first-hand experience, I highly recommend John and his services.

Bill Graveman

President / Biomedical Devices of Kansas, LLC

John adheres to the highest principles of integrity and ethics. His work has always been comprehensive and complete. He is a pleasure to work with.

George Green, PhD

President / Cerebotix

ManaMed is a medical device distributor and manufacturer. John was a huge help in our 510K application process. John Ziobro, is a FDA applicant reviewer and we can safely say he is one of the best in the industry. It is without question that he has all the tools and skills to guide a device maker through the rigorous 510K process. Without a doubt, I highly recommend Mr. Ziobro and his affiliates. He is professional, honest, and a hard worker. We would hire him again for our next 510K.

Trevor Theriot

President / ManaMed

As a small startup company developing a new product, we needed an outside resource that could quickly understand our business model, product and regulatory pathway while developing our quality management system. Initially I thought this would be an impossible task, but after our first meeting with John, we knew we had found the team that could help us. SpectraMedEx understood the idiosyncrasies of our startup business and quickly developed a top-notch quality management system and trained our employees on its use. John and his team were an integral part of getting our company off the ground.

Sean Dingeldein

CFO / Enhancement Medical

I engaged John Ziobro at several companies including VibeTech and MPE. John has excellent experience, expertise, and practical knowledge for medical device and biotech companies that need professional support with quality systems, regulatory compliance, new product development, and other services. John assisted our Management Team at MPE with a process to become ISO 13485 certified in a tight timeline. John set up a practical plan and detailed road map with appropriate controls which led to a successful and timely certification. He guided us and worked with us every step of the way to ensure the positive outcome. John is a tremendous resource and I highly recommend him.

Gary R. Les

President/CEO / MPE

John is a terrific innovator and visionary. He is a hard working and trustworthy businessman. Every organization needs a John Ziobro. I enthusiastically recommend John without hesitation.

John Louis

President / AcuForce

John was just great when you consider that I live in the UK and John in the US. Trust him120% could not ask for any better.

Ian Ferguson, MD

Founder / Airlet Medical Systems, LLC

John at SpectraMedEx was an excellent resource for our company. He diligently helped us find a solution to our manufacturing and developmental needs. His advice was key in finding solutions to the challenges we were faced with.

Brent Walker

President / Reach Medical

John has been helping us since the beginning, coaching us in every aspect of the FDA pathway. He first helped us to understand device classification, shared FDA and CE-related documentation that saved us a lot of time, and taught us about manufacturing and quality systems requirements. He is continually very generous about making intros to others who can help us. John’s wisdom is helping us to craft an effective strategy for our development process that not only saves us time and money, but also makes it clear to others (like investors) that we understand our regulatory position and know how to manage the associated risks.

Katie Brenner, PhD

Co-Founder / blyDiagnostics

John Ziobro was a tremendous resource for us during our recent 510(k) filings and our FDA audits. He has also assisted us with the proper forms and schedules of our ISO 13485 Quality Manual to make sure they are in compliance with FDA regulations. He was very responsive to our needs, and very knowledgeable about the process and requirements. He was, and is, very accessible, always returning calls and/or responding to emails in a timely manner. We highly recommend his services.

Nelson Hardin

President & CEO / ElectroCap International

As a small organization with multiple FDA approved devices, Essential’s needs for a highly skilled medical device expert in regulatory and quality is critical. Further, our needs require the ability of this expert to understand the requirements and resources of our specific organization. SpectraMedEx is just that company. Working directly with John Ziobro, we have found a new level of efficiency and understanding in the regulatory arena. John’s ability to understand our organization through a learning process and specify work to our particular situation is invaluable. Further, his unique approach to quality planning and implementation lets any size company quickly and efficiently implement these necessary procedures. As the regulatory and quality world is constantly evolving, we will continue to look to SpectraMedEx for our needs.

Allan Weber

CEO / Essential Pharmaceuticals

We refer to John as the FDA man. If we have a question he has an answer, precise, and concise. John’s explanations also include the questions we did not even know to ask, and his advice is always a practical approach to the requirements. SpectraMedEx has been a Godsend to QuadJoy, and has enabled us to help the disabled at an affordable cost.

Bill Street

President / Quadjoy

Competent and excellent insight in FDA regulatory affairs

Bob Boveja

CEO / ABL Technologies, LLC

As a CEO for a small and growing company, I have hired John for the past four years and he has successfully completed 510K submissions and numerous compliance documents for Blackrock. John's knowledge, professionalism and energy make him a pleasure to work with. Above all else, John impresses with his highly systematic processes and procedures to complete projects efficiently and on time. John earns my highest recommendation with his regulatory expertise, candor and proficiency.

Andy Gotshalk

CEO / Blackrock NeuroMed & Blackrock Microsystems

SpectraMedEx has been great to work with. We are a small startup with a big, complex product and we need processes that are enabling rather than burdensome while we are small, but that can handle our anticipated growth. They understand our needs without having to be told and have done this enough times that they can guide our implementation, beyond just responding to our requests. And beyond their professionalism and expertise they are just pleasant people to work with.

Steve Hushek

President / Medtrak

We are a Spanish manufacturer of neuronavigation system for surgical applications. We have been collaborating with SpectraMedEx company in the past and it was a very satisfactory collaboration. We recommend to work with SpectraMedEx due the big experience in this field and the big results obtained.

Fdo. Ernesto Vallet

CEO / NaviMetric

As a CEO for a small and growing company, I have hired John for the past four years and he has successfully completed 510K submissions and numerous compliance documents for Blackrock. John’s knowledge, professionalism and energy make him a pleasure to work with. Above all else, John impresses with his highly systematic processes and procedures to complete projects efficiently and on time. John earns my highest recommendation with his regulatory expertise, candor and proficiency.

Andy Gotshalk

CEO / Blackrock NeuroMed & Blackrock Microsystems

Thank you John Ziobro for being such an efficient and effective consultant who actually changes, teaches and implements the requirements. It is very rare to see an external consultant taking the risk with you and spending hours on brainstorming. No need to mention your generosity in sharing your experience and knowledge unlike other consultants. Your remarks on our system and support will always be appreciated by our Group. It is always pleasure to work with you.

Ayşem Ferda SEVİNÇLİ

Kalite Direktörü / Meditera Group