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June 7, 2023

Do We Need a Call?

Dr. Oliver Eidel

Hey!

Thanks for your interest in talking to me. First off, I’m also interested in talking to you!

This is not about me trying to make people go away. Instead, it’s about how I can help you the most without going crazy and questioning my life choices every morning. Medical device regulation is already very broken and frustrating and it’s hard for me to continue working in this field while also having 8-10 back-to-back calls every day.

I’ve noticed that startups often ask me the same questions, so a more efficient way is to answer them on this website and via email. This has the benefit of saving both of us a lot of time, with the additional benefit of me not going crazy.

But, in some cases, calls still make sense! It depends on what you’d like to talk about. If you have some time, I’d appreciate you reading on to see which situation might describe you best:

Exchanging Information

You have general questions about medical device compliance. Maybe you’re considering founding a startup in this area and want to learn which regulatory requirements apply to you (this also includes building an early-stage startup in an incubator). You also might want to learn how you can get help, e.g. through consulting from us or by using eQMS software like ours (Formwork) to automate things. This also includes general questions about Formwork, its features and its pricing.

In this case, I don’t think we need a call as it’s mostly about exchanging information. Most of the information you seek is already on this website. Our most frequent questions and answers are listed on the before our call page, more questions and answers are on our questions page. If you’re interested in our software, check out Formwork (watch the video there!), and if you’re interested in our consulting, check out Headstart.

If your question still remains unanswered, send me an email and I’ll be happy to schedule a call with you!

Exchanging Complicated Information

You have questions but they are very complicated and would lead to lots of email ping-pong. Typical examples for this are that you’re currently undergoing an audit and the audit report is super hard to understand and you have no clue what to do. Or your current consultant sucks and you’re not sure if switching consultants makes sense. Or your current eQMS software sucks but you’re not sure if it’s “just you” or it really sucks.

In this case, it makes sense to have a call. Feel free to schedule a call here but please review all the relevant links I already mentioned above, especially our frequently asked questions.

Networking

You have nothing specific to talk about but would just like to meet for something like a “virtual coffee”. The goal here is to get to know each other and just keep each other in mind in case we might work together in the future, without having a specific project in mind. Now you might expect me to shout “makes no sense, send me an email!” but my opinion actually is the complete opposite: I think a call makes a lot of sense here because “getting to know each other” can’t be replaced with emails.

So feel free to schedule a call.

Your Situation Not Covered?

Your situation is not mentioned above? Just send me an email.

Looking forward to meeting you, via email or via a call! :)

Oliver

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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Dr. Oliver Eidel

I'm a medical doctor, software engineer and regulatory dude. I'm also the founder of OpenRegulatory.

Through OpenRegulatory, I've helped 100+ companies with their medical device compliance. While it's also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)

If you're still lost and have further questions, reach out any time!

Comments

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No QMS on this planet will save you from creating crappy software.