Regulatory + Quality Assurance | Michelle Lott | lean RAQA

Regulatory Strategy

Why Is Regulatory Strategy Important?

Many medical device companies see “everything regulatory” as a burden. That’s a matter of perspective. The leanTeam sees regulatory strategy, done right, as a competitive advantage. So do our clients. Are there lots of forms and confusing/changing regulations? Sure, and you can look to the leanTeam to help you navigate the process.

But the thinking, the planning, the strategizing for your business? That’s very much worth your time and talents. Engaging a team who lives regulatory all day long, researches it and EVEN enjoys it, will make you more effective.

Do You Have Any Questions?

Project work varies greatly around here at leanRAQA. Some clients “just have a question.” They “just like knowing they can call us” whenever the need arises. Others have an audit in two weeks(!!) YIKES(!!)

The reason for your visit to our site today (thank you!) probably falls somewhere between a question and a crisis. You’re looking for something specific, and chances are I have it, so don’t just scroll aimlessly (although the new website IS pretty cool). Put some time on my calendar and we’ll chat.

Nobody has time for antiquated nonsense

Are you afraid I’ll put you on some big list and try to sell you all the time? Well, newsflash….
nobody has time for that antiquated nonsense. You don’t. And we definitely don’t. So, if you’ve
got a question about regulatory strategy, just ask us already.

LET’S TALK

Why Do You Need A Strong Regulatory Strategy?

First, you’re going to do regulatory anyway. It’s unavoidable. So if you’re doing it anyway, do it smartly. With a qualified team, like us. Do it smartly and in the least burdensome way. Beat your competition while you’re at it.

SECOND, A STRONG REGULATORY STRATEGY LETS YOU:

Get money

Investors like knowing what they’re investing in.

If you can’t effectively project costs, timelines, and testing, you ain’t getting the money. Sorry about that.

Skirt death

Come to Arizona, buy me a glass of wine, and I’ll tell you about the clients who should have called me sooner. Because when you get caught being out of compliance, you’re already in a ditch.

I can help you out of the ditch, sure. But you’ll need shovels to cover up that huge hole. 

 

Probably a landscaper too. All could have been avoided, just sayin’.

Expedite clearance

Without a strong regulatory strategy, your submissions risk getting sucked into a bureaucratic vortex. Oh, the time wasted going back and forth for a change here, an edit there.

It adds up and pushes your launch back further and further.

Michelle is a “no shit” expert in helping start-up companies with FDA. She sits on an FDA advisory committee, helped […]

Dr. Mark Adkins
Founder, AK Collaborations

Dr. Mark Adkins

Contents Of A Strong Regulatory Strategy

You’ll see. It isn’t so bad. And I can help you with each.

  • Clear intended use and indications statement
  • Product type determination
  • Product code determination
  • Product classification
  • Identification of any exemptions
  • Itemization of applicable recognized consensus standards
  • Itemization of applicable FDA guidance documents
  • Analysis, costs, risks and recommendation for submission options
  • Analysis and recommendation for test strategies based on standards and guidance documents
  • Review of changing regulations, policies, or politics that may affect product clearance
  • Quality Management System requirements, costs, and resources post commercialization

Help Has Arrived!

Pick an open half hour on the calendar. Maybe we can lighten your workload and we would LOVE to help!

let’s connect!