Hurdle Regulatory Obstacles from Strategy to Execution

When you enter the medtech or medical device industry, you’re instantly confronted with regulations you might not know how to navigate. There are mountains of paperwork and rules you might not have time to read through, interpret and keep up to date on. That’s where QuickConsult comes in.

The experts in our deep network of medtech professionals range from experienced regulatory consultants to ex-FDA Office of Drug Evaluation reviewers. When it comes to regulatory consulting and questions, QuickConsult is your go-to hub of experts you need. Whether you’re in the market already and need regulatory updates or you’re just getting started and need a regulatory road map, we are the partner you’ve been waiting for.

How will FDA regulatory updates impact you and your company? How do you prepare for a 510(k)? How do you get your medical device into the European market? These are all questions our experts know the answers to. When you work with QuickConsult, you pick the regulatory professional right for you. Save time and money by getting the answers you need now.

What Is Regulatory Consulting?

When it comes to regulations for your medical device or technology, there are a seemingly endless number of topics to be covered. From the very basics about submissions to the best strategies moving forward, QuickConsult’s experts can help you with your regulatory questions faster than you ever thought possible.

Regulatory consulting can include preparing marketing submissions, 510(k) submissions, premarket approvals and more. From beginning to end, QuickConsult is outfitted with some of the most experienced professionals in the medtech industry. From early planning stages to final execution, we can strategize, support and implement your regulatory methodologies.

Here are some common regulatory areas QuickConsult can help you with today:

510(k) (traditional, special, abbreviated): Also called a Premarket Notification (PMN), this must be submitted if you plan on introducing a medical device for commercial distribution or if you are reintroducing a device that was significantly modified.

De Novo (Evaluation of Automatic Class III Designation): De novo classification requests are submitted to the FDA after you receive a “not substantially equivalent” (NSE) determination in response to your 510(k) submission. You can also prepare de novo submissions for low- to moderate-risk medical devices without having to first receive an NSE determination.       

Premarket Approval (PMA): Premarket Approval is necessary for Class III medical devices. Because of the high level of risk associated with Class III devices, the FDA has to evaluate the safety and effectiveness of these devices with more than general controls. This approval is required before marketing can begin.

Technical Files / Design Dossiers for CE Mark: Want to market your device outside of the U.S.? QuickConsult can help you with that. U.S. and EU requirements can very greatly—even for products that have fulfilled FDA PMA requirements, navigating the EU’s requirements to obtain a CE Mark can be complicated. Our experts can help you with any questions you have from start to finish.

ISO Standards: International Organization for Standardization standards can be tricky to understand, yet they are required to ensure the industry’s quality system expectations and regulatory requirements.

513(g) Request for Classification: For when your medical device doesn’t match a predicate device in the FDA classification database. For example, if your device is particularly innovative, it may be hard to classify. Writing and submitting a 513(g) “provides a means for obtaining the [FDA’s] views about the classification and regulatory requirements that may be applicable to your particular device.” We can help you establish when and how to submit these requests.

Our expertise doesn’t stop there. We can help you figure out exactly what you need to begin or expand your regulatory strategies. From guiding you through steps to meet regulatory requirements across the globe to writing or proofreading your submissions, our experts can help with so much more:

  •   Humanitarian Device Exemption (HDE)
  •   Strategy Review
  •   Technical Writing
  •   Proofreading and Editing
  •   Drafting and Communicating Submissions
  •   Technical Files / Design Dossiers for CE Mark
  •   Canadian License Applications
  •   Europe, Middle East, and Africa (EMEA)
  •   Asia Pacific (APAC)
  •   International Conference on Harmonisation (ICH) Guidance Documents
  •   Combination Products
  •   Device Description and Specifications
  •   Intended Clinical Applications
  •   Labeling Claims
  •   Available Test Data
  •   Literature References
  •   Predicate Review
  •   Guidance Document Interpretation
  •   Pre-submission Support Documents
  •   Investigational Device Exemption Applications (IDE’s)
  •   Medical Devices Directive (MDD)
  •   Active Implantable Devices (AIMD)
  •   In-Vitro Diagnostic Devices (IVDD)

Regulatory consulting can spare you the headaches, time and costs of working through regulatory red tape on your own. Whether you’re a medtech startup or Fortune 500 company, our experts can step in for one-time questions you have or clarifications you may need, or we can fill in as the perfect supplementary assistance you need through the entire life of your medical device. No question will go unanswered.

Our broad range of expertise is hard to find. Our experts are thoroughly vetted, so you can ask away with the peace of mind that comes with consulting a trusted and experienced source.

Get the Medtech Consulting You Need Now with QuickConsult

You created a medical device to help people who need it now. With quick and accurate regulatory consulting, you can get your device on the market in a fraction of the time than if you try to navigate the hard stuff by yourself. Get in touch with us today and clear regulatory hurdles sooner.

QuickConsult Regulatory Experts Are Waiting

QuickConsult experts have experience across numerous product and therapeutic areas, including but not limited to cardiac rhythm, cardiovascular, diabetes, ear, nose & throat, gastroenterological, general surgery, medical supplies, neurological, orthopedic, patient monitoring and recovery, reconstructive / plastic surgery, spinal, surgical innovations, urological / urogynecological, vascular therapies, and mobile apps. Their expertise spans management to executive level backgrounds in Fortune 500 organizations to startups. Some experts use to work directly at the FDA.

“QuickConsult is like having a really good friend who’s a really good expert, in your back pocket, that you can … ask a tough question! [QuickConsult] provides that network in a way that is easy access, vetted people in an environment that you can trust and be protected. I think that’s invaluable.”

– Susan Alpert, MD, PhD, former FDA Director, former Medtronic SVP

Helpful Links

FDA Office of Device Evaluation

FDA – Overview of Device Regulation

FDA – About the Office of Regulatory Affairs

FDA – How to Study and Market Your Device

European Union (EU) Regulatory Framework

Ask your Regulatory Consulting question now