Picking the Right Regulatory Consultant for Your MDR Certification

Let's start simple. A regulatory consultant is the person who guides you through getting your medical device approved in Europe.  Most companies have never tried to get a product CE marked.  Your strengths is in the product innovation, healthcare understanding, business understanding - and very rarely in the regulatory domain. 

That's why most companies decide to use an external consultant, who have done this before, that can guide them in the process of choosing the right Notified Body, discuss the regulatory strategy and help write and defend the paperwork that gets checked by a Notified Body. 

Some companies think this is a short-term check-in-the-box activity. But it's not. You most often work with the consultant for +1 year, and he/she should both act as you trusted advisor and expert, but also in helping you and your team to build up the right internal culture, knowledge and competencies. For going forward almost all organizations, can not outsource this. You will need to build regulatory skills inhouse. Since even after you get CE mark, you will continue to have audits, you will also most like make new versions/new products, legislation will change, you will enter other legal jurisdictions etc.  

At first, every consultant sounds about the same. They all use the same words, like "strategy" and "compliance" and "timeline." It's hard to tell them apart from a sales call. The real differences only show up months later, when your file gets rejected, or your timeline runs past the point where your funding lasts. 

This role sounds like paperwork. It isn't. A weak consultant can hand you a file that looks correct on the surface, and it can still get rejected. That's because reviewers aren't just checking that the paperwork is filled out right. They're checking whether the actual content holds up. 

Three problems that won't wait for you to catch up 

1. Someone promises too much. 
No consultant can guarantee what a Notified Body will decide, or exactly how long it'll take. If someone tells you they can guarantee that, they're telling you what sounds good, not what's true. If you believe them, you'll plan your funding around a date that was never real to begin with. 

2. The file looks copied and pasted. 
Some consultants reuse the same templates for every device, even when the devices are completely different. Reviewers at Notified Bodies see this all the time, and they catch it fast. If this happens to you, you end up back at square one, months later, with a rejection letter instead of an approval. 

3. The person who pitched you isn't the person doing the work. 
Sometimes an experienced person sells you on working together, but then a junior team actually handles your file, while also juggling several other clients. Nobody tells you this upfront. You usually only notice once a deadline gets missed. By then, fixing the relationship costs you time you didn't have to spare. 

What to actually do. Start early, and do these five things. 

1. Ask for real examples, not just a résumé. Someone who's worked on one type of device hasn't necessarily worked on your type of device, or your kind of software. Ask for specific, similar cases. That tells you far more than years of experience on its own. 
2. Ask who will actually be doing the work. Get an actual name, not just a description of "our team." And ask what happens if that person leaves partway through. Ask this before you sign anything, not after. 
3. Get a clear, written scope, not just a day rate. Know exactly what's included, and what counts as extra. A vague agreement is how something that sounded reasonable turns into a much bigger bill than you expected. 
4. Is the consultant also a good teacher? Is the consultant able to communicate to you and your team in a way you understand it? Many consultants in the regulatory field speak a language normal people do not understand. And you do need to understand it, since it’s your company's responsibility in an audit – not the consultant’s responsibility. And therefore, the consultant both need to be a good expert and a good teacher, that communicates and teaches you in a way that fits you.  
5. Is this someone I like working with? There has to be chemistry mutually, since this is in many ways like hiring a new co-worker. Since this is  a relationship that is likely to exist for long. 

Before the wrong consultant becomes the expensive one 

Most consultants know their stuff. The real gap is usually that a founder never asked the uncomfortable questions before signing, because everything felt urgent and every option looked the same. 

You shouldn't have to guess who's actually qualified based on one sales call. healthtechpathways.org keeps a directory of consultants, showing their real experience, the device types they've worked on, and what they specialize in. So you can compare your options before committing to anyone. 

Browse consultants and their track records at healthtechpathways.org, before you sign with anyone.