If you’re lost in regulation, don’t worry! You’re not alone. Sometimes we are lost in regulation, too.

But it’s not hopeless! Check out the sections below to see if one of them describes your situation. Each section lists the options you have. Good luck! :)

Your Situation: You’ve Just Founded a Startup And Have No Idea About Regulation.

You’ve just founded a startup or are close to founding one. You are considering developing medical software and are not sure whether it’s a medical device or not. You also want to learn about how much effort it is to bring a medical device to market, how long it takes and how much it costs.

Don’t worry, that’s a common situation and we’ve answered those questions hundreds times before! Here are your options:

• Send us a message and schedule a call: If you’d like to talk to a human and are considering hiring us as consultants, we’re happy to help any time! Send us a message and, we’ll respond quickly. We can also schedule a call. Emails and first calls are always free!
• Watch the free starter video course: It just takes 30 minutes of your time and will likely answer 99% of your questions. And it’s free!
• Check out the Wizard video course: The Wizard video course is similar in spirit to the starter video course, but it covers everything in medical device compliance from start to finish. It’s not free, but it’s a one-time purchase and you get unlimited access.
• Ask other people in our OpenRegulatory Slack Community: Join our Slack community in which 900+ people from Healthcare companies all over the world share their regulatory experiences and how to succeed in audit. Completely free!
• Read articles and questions and find answers: Browse our articles and questions we’ve answered.
• Join the next free consulting call: We regularly host a free consulting call in which everyone is invited to join and ask their regulatory questions.

One interesting note here: We’ve seen many founders ask us about our eQMS software, Formwork. Our recommendation is this: You should understand first what sort of compliance documentation you need to create before attempting to automate it. This is a bit like an author looking for text editor software without knowing what to write. Postpone the decision on QMS Software until you have a better understanding - the Wizard is probably the best way to get that.

Still, eQMS software is important - so take a look at Formwork if you’re interested!

Your Situation: You Have Some Documentation, But You’re Not Done Yet.

You’re not starting out from scratch - you already have some documentation which was either drafted by someone from your team or by another consultant. But now, you need help. Either you’re stuck and your progress has come to a halt and you’re looking for help, or you think you’re done and need someone to review it and check whether it’s complete.

• Send us a message and let’s see if we can figure out how to help. Emails and first calls are always free!
• Check out Formwork, our eQMS software: Another way of speeding things up might be to use eQMS software, and Formwork is probably the most suitable software for startups.

Your Situation: You’re Already On The Market, But There Are Problems.

You’re already on the market, but things are not running smoothly. You’d like to make things more efficient because regulatory compliance causes a lot of overhead and you take forever to ship changes to your medical device. Or, you’re short on employees and need some external help to get stuff done.

• Send us a message and let’s see if this is a project we can help with. Emails and first calls are always free!
• Check out Formwork, our eQMS software: If your current eQMS software sucks or you don’t have one yet, consider Formwork as it has the most automations any eQMS software has to offer.

Your Situation Not Covered Here?

If your situation is not covered by the examples above, send us a message so that we can figure out how to help you and also improve this page in the future!