Food for thoughtIndustry News
May 29, 2024

Common Mistakes Startups Make When Submitting to the US FDA

While medical device startups may have innovative ideas and technologies, they face significant hurdles in obtaining regulatory approval compared to well-established corporations.  Some of these challenges are due to the…
Fang Consulting
BusinessUncategorized
May 15, 2024

PRESS RELEASE: Time is Running Out: All MDD Certificates Expire May 26, 2024

FOR IMMEDIATE RELEASE May 15, 2024   Time is Running Out: All MDD Certificates Expire May 26th, 2024 Roseville, MN, 05-15-2024 – All MDD certificates are set to expire May…
Fang Consulting
Uncategorized
February 27, 2024

Fang Consulting No. 102 on Inc. Magazine’s List of Fastest-Growing Private Companies

Fang Consulting is happy to announce that after a two-year growth in revenue by 111.3%, our company ranks No. 102 in Inc. Magazine's List of the Midwest's Fastest-Growing Private Companies.…
Fang Consulting
BusinessUncategorized
April 4, 2023

What to Know About De Novo

What is De Novo? The De Novo classification request provides a pathway to classify novel devices (class I or class II) for which general and/or special controls provide a reasonable…
Fang Consulting
mdr submissionBusinessFood for thoughtIndustry News
March 28, 2023

What is a 510(k)?

The United States Food and Drug Administration (FDA) regulates medical devices sold in the US through a pre-market review process. One of the most commonly used pathways for the review…
Fang Consulting
EU MDR
February 24, 2023

Public Health Emergency Expiring: What Will Happen to EUA’s?

Public Health Emergency Expiring: What Will Happen to EUA's? The COVID-19 pandemic has had a profound impact on public health and the economy worldwide. In response, the US Food and…
Asia Enger
Industry News
July 28, 2022

Why FDA’s Cybersecurity Draft Guidance is a Controversial Change

On April 8, 2022, the FDA released an entirely new draft guidance for premarket medical device cybersecurity, expanding upon previous recommendations from the public on its 2018 draft guidance. If…
Lily Vucenich
EU MDRIndustry News
July 21, 2022

Post Market Clinical Follow-Up Under EU MDR

Do you wish to market your product in the EU? Well, things just got more complicated. Under the new EU MDR, CE- Marked devices must now meet much more extensive…
Lily Vucenich
EU MDRIndustry News
July 12, 2022

EUDAMED Timeline Update

On July 6th, 2022, the European Commission released an updated version of the EUDAMED timeline. This version delays important milestones by exactly 1 year, meaning the “full functionality” of EUDAMED…
Lily Vucenich
vaccineIndustry News
June 23, 2022

EUA Update: FDA Announces Intent to Withdraw Guidance

By Lily Vucenich  |  June 23, 2022 As of June 7, 2022, the Food and Drug Administration (FDA) has announced their intent in the Federal Register to withdraw the guidance…
Lily Vucenich
Medical Device RegulationIndustry News
July 26, 2021

Links in the Chain: Economic Operators under MDR – Who They Are, What They Must Do… and Whether You Might Be One

Imagine that you’ve discovered a problem with a medical device – maybe something that makes the device downright dangerous, or maybe something that just makes it less effective than it…
Fang Consulting
mdr submissionEU MDR
July 21, 2021

MDR NB Common Submission Issues and How to Prevent Them

Fang’s internal processes and checklists have evolved over the last 3 years since we started working heavily on MDR transitions for our clients. The process improvements have been driven by…
Fang Consulting
maddieCompany News
July 12, 2021

Questions and Answers With Maddie

If you’ve been to the office or seen the back of one of our business cards, you know that Maddie Eberly plays a central role in the office. We are…
Fang Consulting
510kIndustry News
July 6, 2021

The Rise and Fall of the COVID-Era EUA: Why You’re Better Off with a 510(k)

By Leslie Williams  |  July 6, 2021 Milk or dark chocolate? Paper or plastic? Mountains or the beach? EUA or 510(k)?The Emergency Use Authorization question may not be as polarizing…
Fang Consulting
Industry News
July 6, 2021

What is a 510(k)?

The FDA generally requires manufacturers to demonstrate that a new medical device is safe and effective, i.e., substantially equivalent (SE), to an already legally marketed device via a premarket submission…
Fang Consulting
canadaIndustry News
June 16, 2021

Expanded Canadian Regulatory Amendments

In December 2018, Health Canada (HC) launched the Medical Device Action Plan (MDAP). The plan is in an effort to improve the safety and effectiveness of medical devices and to…
Fang Consulting
medical deviceIndustry News
June 14, 2021

Rise of the Machines: Regulating Medical Device Software

By Leslie Williams  |  June 14, 2021 In the Terminator movies, the freakishly badass silver machines rebelled against their human creators and set their glowing red eyes on a single…
Fang Consulting
medicinal substancesProducts
June 1, 2021

Medical Devices, Medicinal Substances – and Memorex

By Leslie Williams  |  June 1, 2021 Is it a drug or a medical device? Or both? The old “Is it Live or Is it Memorex?” commercials from the 1970s…
Fang Consulting
medical deviceEU MDR
May 26, 2021

Class I Devices Under MDR: To NB, Or Not To NB?

Note: The following discussion applies to non-custom, non-investigational medical devices. If you manufacture medical devices for sale in the European Union, you’ll have to show that they conform to the…
Fang Consulting
medical device softwareProducts
May 17, 2021

How Do I Know if My Software is a Medical Device?

By Leslie Williams  |  May 17, 2021 As our world becomes ever more digitized, software has begun to infiltrate every minute of our day. We wake to the alarm on…
Fang Consulting
Legacy Medical DeviceIndustry News
May 4, 2021

The Wait is Over: What MDR Means for Your Legacy Medical Device

By Leslie Williams  |  May 4, 2021 Unless you’ve spent the past few years marooned on a small and completely unconnected desert island, you know that the new Medical Device…
Fang Consulting
covid vaccineIndustry News
April 20, 2021

The Long and Winding Road: Regulatory Pathways for Vaccine Approvals

By Leslie Williams  |  April 20, 2021 If the COVID-era emergency use authorization process has taught us anything, it’s that the standard, non-emergent regulatory approval process for vaccines and other…
Fang Consulting
EU MDRIndustry News
April 2, 2021

MDD to MDR – The Why, What and How of the Approaching Transition

By Leslie Williams  |  April 2, 2021 The medical device industry is set to fully implement the much-anticipated EU Medical Device Regulation (MDR) at the end of May 2021, after…
Fang Consulting
medicalEU MDR
March 22, 2021

Stay Calm and Carry On: What Brexit Means for Your Medical Device

By Leslie Williams  |  March 22, 2021 Much has been said about the fast-approaching transition to the Medical Device Regulation (MDR) in Europe and its impact on the global medical…
Fang Consulting
emergency use authorizationIndustry News
March 5, 2021

A Look Back at the Emergency Use Authorization, and What Lies Ahead

By Leslie Williams  |  March 5, 2021 Despite advance warning and gloomy predictions, the eruption of the COVID-19 pandemic caught governments and healthcare systems completely by surprise. On a global…
Fang Consulting
medical deviceProducts
February 22, 2021

Is Your Product a Medical Device? The Devil is in the Details.

By Leslie Williams  |  February 22, 2021 As a medical device manufacturer, how do you know if your product is a medical device? Unfortunately, the answer to that question is…
Fang Consulting
medical deviceIndustry News
November 19, 2020

Tracy Eberly Discusses COVID-19’s Impact on Medical Device Companies

The COVID-19 health crisis has had a large impact on a plethora of sectors, with the medical device industry appearing as no exception. Many companies within the space have experienced…
Fang Consulting
BusinessEU MDR
November 19, 2020

Tracy Eberly and Fang Consulting Discuss Choosing the Best Firm for Your Needs

In a field as innovative and diverse as the medical device industry, finding the right consulting firm for your company has the potential to be a stressful experience. In determining…
Fang Consulting
Company News
April 1, 2020

Growth

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…
Fang Consulting
Company News
April 1, 2020

Escape Room – Escaped!

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…
Fang Consulting
EU MDR
April 1, 2020

Notified Bodies

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…
Fang Consulting