International market access for medical device companies

Plot Your Own Course

Expanding into new markets can be challenging for small medical device companies. You've likely spent a year or more focused on the product itself โ€” testing, documentation, your first regulatory approvals.

Now what? Where do you go? Who do you talk to?

That's where we come in. For a flat monthly rate, we give you the tools to:

โœ“ Built specifically for small medical device companies
โœ“ For everyone at your company โ€” up to 25 users
โœ“ We help you identify, qualify and manage distributors.
โœ“ Easily monitor competition and better evaluate new markets.
โœ“ Free onboarding with every engagement
โœ“ Ongoing check-ins, not a one-time report
What we do

Market access support for medical device companies going international

We provide you with the information you need to make the decisions โ€” built around the specific problem of selling a regulated device in more than one country.

We work through the questions that come up at every stage of an international expansion: which markets make sense for your product, who else is already active there, what the registration process actually involves, who could distribute for you, and what it's realistically going to cost and take.

We don't assume an answer. Not a market you should enter, not a route you should take, not a partner you should sign. We lay out what each option involves, and leave the decision where it belongs. You expand at your own pace, in the order that suits your product and your cash.

The alternative most teams live with is a spreadsheet somebody built two roles ago, scattered regulator websites in languages nobody on the team reads, and consulting engagements that start over from zero every time. We built this so that work doesn't have to happen from scratch every time you look at a new market.

What you get help with

The questions that come up at every stage

Every market answers these differently โ€” in a different language, a different process, a different set of players. We help you work through them one market at a time.

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Which market should you enter next

Where your product is likely to fit, based on the regulatory pathway, the competitive landscape and what it would take to get there โ€” so you can compare options instead of guessing.

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Who else is active in that market

The competitors already registered or selling there, so you know what you're up against before you commit.

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Who could distribute for you

Local distributors and partners worth talking to, and the questions worth asking them before you sign anything.

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What registration actually involves

What the regulator requires, who is allowed to hold the registration, and a realistic timeline โ€” not a generic overview.

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Staying ahead as things change

Markets move โ€” a competitor registers, a rule changes, a renewal comes due. We keep an eye on it so you're not caught off guard.

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Someone to actually ask

When something doesn't look right or a decision needs a second opinion, you reach a person who knows your situation โ€” not a support ticket.

Where we work

Asia-Pacific, Europe, the Americas, the Middle East and Africa

Every region has its own regulatory landscape and its own set of players โ€” and its own reasons to go there first. Taiwan, for instance, is a common early market for US manufacturers; a market like Brazil answers a very different question. We help you work out which order makes sense for you.

Or start with the region you're weighing โ†’

How it works

Plot your own course, with us alongside you

A straightforward process, built around your product and your pace โ€” not a fixed package.

1

Tell us about your product and your goals

What you make, what markets you're weighing, and what "success" looks like for this stage of your company.

2

We work through the options with you

The markets that fit, who else is active there, what registration involves, and who could distribute for you.

3

You get a clear recommendation

Not a generic country report โ€” a specific view of where to go, in what order, and why.

4

We stay with you as you execute

Ongoing check-ins as things move, and a person to ask when something needs a second opinion.

Plot Your Own Course

You know your product best. We help you identify the opportunities, the distributors, and the other connections you need to grow globally โ€” on your timeline, in the order that makes sense for your company.

Request a demo → Ask a question
What comes with it

You are not left to figure it out alone

Advice is only worth what you can act on. Every engagement is set up around your products and the markets you're weighing, and the help does not stop after week one.

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Free onboarding and setup

We start with your products, your competitors, and the markets you're weighing โ€” so the first conversation is about your own situation, not a generic pitch. No charge, on every engagement.

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Quarterly check-ins

Markets move. Every quarter we walk through what changed, what's new for you, and what's worth doing next. Included, not an add-on.

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Support from people who know your situation

When something doesn't look right, you reach a person, not a ticket queue. If a market or a decision needs a closer look, tell us โ€” that's the kind of question we like.

FAQ

Questions we get asked a lot

How do I know which market to enter first?
It depends on your product, your regulatory class, and how much runway you have โ€” a market that's easy to enter can still be slow to pay off, and vice versa. We work through the trade-offs with you rather than hand you a single "best" answer. Ask us about your specific situation.
Can you help me find competitors and distributors in a new market?
Yes โ€” that's a lot of what we do. Knowing who else is active and who could realistically sell for you is usually the hardest part to figure out from outside the market, and it's where we spend most of our time with clients.
How long does registration typically take?
It varies a lot by market and device class โ€” anywhere from a few months to well over a year. We'll give you a realistic timeline for your specific product rather than a generic range.
Do you work with early-stage companies that don't have a product on the market yet?
Yes โ€” we have a program built specifically for that stage, including check-ins and setup help while you get ready to expand. Ask us about it.
How many people at my company can use it?
It's built for everyone who needs it, not just one person โ€” up to 25 users at your company on a single engagement. If you need to track more than one company (a group with multiple brands, for example), additional company profiles are available for an additional monthly fee.
How do I get started?
Talk to us first. We'd rather spend twenty minutes understanding your products and the markets you're weighing than hand you a generic package โ€” so the first conversation is about your own situation. Onboarding is free, and every engagement includes ongoing check-ins. Request a demo to get started.
We're a small consultancy โ€” do you work with teams?
Yes โ€” talk to us. We work with consultancies regularly and can structure things around how your team actually runs engagements. Reach out at inquiries@meridiantrace.com.
Talk to us

We respond to every email.

Not sure if it's the right fit? Have a specific research question? Want a discount? Just ask โ€” there's a person on the other end, not a ticket queue.

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Request a demo

See yourself in our solution โ€” tell us your products and markets, and we'll show you what it looks like.

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Ask a question

Not sure if it's the right fit, or want to know about pricing? Just ask โ€” there's a person on the other end.

Email inquiries@meridiantrace.com โ€” we reply within one business day.

See yourself in our solution

Tell us your products and the markets you're weighing, and we'll show you what it looks like for your own situation. Onboarding is free, and quarterly check-ins come with every engagement.