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Results Oriented 
Submissions and Compliance
Global Medical Device Consultants
612-889-5168
Knowledge

"…thanks for your gap inspection work and your audit readiness help. Moving forward, I may want to get some ideas from you regarding our FDA inspection readiness strategy…" 

“MedTech Review’s expertise in Asia Pacific regulations and product approval processes is impressive. They were hired to work on a specific project, but we soon realized that MedTech Review could help us in many different areas. They are efficient, thorough, and willing to share knowledge on a wide range of regulatory topics. We were so satisfied with their work that we extended the contract! I would definitely hire MedTech Review again.”

“John Beasley always seemed to know where the FDA was headed and he had our company in excellent shape before they got there.”

“MedTech’s business sense and deep regulatory knowledge helped us establish our business model but also gave our team – including me – confidence.”

“Extremely adept in their ability to convey and implement the key quality elements of FDA regulations and GMP manufacturing to our team”

“Probably the most knowledgeable people I know in the medical device world”

”Their consultants also provides coaching at key times… John Beasley and his associates are an example of great leaders who know their subject matter well and they care.”

“Under John's leadership, the quality management system recovered from the FDA warning letter to one that is compliant.”


Work Ethic

"Great job on the 510k! A very nice piece of work that really walks the reader through our process."

“We hired MedTech Review to help prepare for our first ISO 13485 regulatory audit. Their in-depth knowledge of quality systems, active implantable devices, regulatory audit experience, and interpersonal skills allowed their consultants to be very effective at helping us in our preparation. In addition, the insight and assistance during the audit were instrumental in our successful ISO 13485 certification and first CE marked product. We enjoyed working with MedTech Review and I hope to have the opportunity to work with them on another project in the future.” 

“John and his team work tirelessly to overcome difficulties.”

 “within six months, our team – consultants and employees together – established document control processes, management control processes, validation processes, service processes and finally, processes to handle non-conforming materials.”


Uniqueness

“MedTech Review was hired by our company as a consultant and I was on the team working with them. I enormously appreciate their constant focus on full compliance with regulations - "good enough" is not in their dictionary. They immediately learn about the company structure they are working with, and team up with people at various levels in the organisation. It was a nice and interesting experience to work with MedTech Review.” 

“John came to work for our company as a consultant, sat at his desk on the production floor and not by himself in some office, and he left our company as my friend.”

“a fascinating ability to think outside the box”

“a pioneer in the way they conduct business”

“ahead of the industry when it comes to dealing with the FDA”


Testimonials


We’re honored to share these comments from clients we’ve served around the world, so that you can better know MedTech Review. Contact us and let’s engage in the conversation that gets you on the path to what you need.