The Fang team has expertise in the most current global regulations and certifications and provides global pre-market submission and post-market support. Let Fang Consulting be your guide through the domestic and international regulatory maze.
Our experienced team knows and understands the ever-changing global quality and compliance requirements and has significant experience creating quality management systems that comply with FDA and ROW regulations. We work with you to customize your quality systems that specifically address your unique needs.
Our “Super CRAs,” with over 80 years of combined experience and who are all licensed professionals in nursing, are able to provide unique clinical support including on-site case support, site training, and CER development and maintenance.
If you are looking for the best path to begin distributing your device, warehousing and shipping solutions and services or if you have questions about how to handle distribution of your product in general, the Fang team has got you covered.
With the EU MDR (2017/745) replacing the current MDD (93/42/EEC) in the EU, many changes are on the horizon and will improve and modernize the current system to ensure the safety of devices. Some of those major changes are the requirements Notified Bodies must conform to once the MDR is in full effect. With the Read more about Notified Bodies[…]
Every few months at Fang, we take an afternoon off to gather as a team and participate in the greatest of team building exercises – Escape Rooms. Our most recent outing was to the Riddle Room in Minneapolis, with lunch at Ray-J’s beforehand to get some brain food for an exciting hour of puzzles and Read more about Escape Room – Escaped![…]
There are many challenges that small, start-up medical device companies face when bringing a device to market – specifically, the act of shipping product to your customers. Also, dealing with the numerous challenges that come after your device is on the market. Sure, you could handle all the shipping and inventory yourself. But your partners Read more about Fulfillment[…]
By 2020 Europe will be moving from MDD to MDR resulting in stricter guidelines for companies distributing into Europe. This change has kept us very busy completing gap analysis and tech file remediation projects for our clients. With this demand we have increased our number of employees and expanded office. We have gone from 5 Read more about Growth[…]
I do what I can to catch the bunnies! Today while on my afternoon walk, I stopped to visit a nice man emptying a cooler into a sewer. I, of course, capitalized on the opportunity to drink some yummy cooler water! Not as good as puddle water, but it sufficed. One always has to hydrate Read more about Madeline and her bunnies.[…]
Feeling fresh and clean! The Holiday Season is here and it is time for a much needed spa day! At Wendy’s Doghouse in Minneapolis , Wendy and her groomers always take such good care of me! There’s nothing like a fresh bath and trim to help freshen me up for my bunny chases (which can Read more about Getting Groomed for The Holidays![…]
It was a rainy day for some tacos! Every Thursday and Friday, a food truck is stationed across the street from the office. It’s a nice break for the staff to take me for a walk, so I love going with them to get their lunch (that they rarely share with me). Today was pretty Read more about Rainy day for a food truck[…]
and they left me at the office! My humans decided they needed a “team building” experience on a Friday afternoon. Personally, I think the best team building is when I take them for a walk and I get to chase bunnies. But they decided to go without me and I was so mad! They went Read more about My humans went to Escape Room…[…]
Today on my usual afternoon walk after chasing some bunnies, we walked by the pond by our office where some baby ducks recently hatched. Mama Duck called for her babies, but 2 did not follow- they were swept away into the drain at the end of the pond. We were all worried, especially me. Luckily, Read more about Saving the baby ducks[…]