You’re in the right place if:

Navigating the regulatory red tape of medical devices feels like you’re stumbling around.

Instead of costly stumbling you prefer having an experienced guide and a good map.

Moving from product development to marketing feels awkward.

You’ve tried all the channels and click campaigns out there, but marketing fails to bring you results.


If you’re stressed out, no worries – I’ve got you!


HI, I’M TIINA TYNI.

Tiina Tyni

I’ll lighten your load as follows:

Idea_ikoni

Regulatory Consultant

I guide medical device companies through the regulatory red tape.

You won’t get lost in the bureaucratic systems.

We’ll find the right route for you.

We’ll complete the required paperwork on time.

Let’s avoid hidden costs and surprises. And get your devices to the market without delays.

Idea_ikoni

Marketing Consultant

I help technical companies avoid the usual marketing bottlenecks.

You don’t need to overspend, stretch yourself to the wee small hours or get overwhelmed by too many options.

Instead let’s focus on things that make marketing a profitable investment.

For example that you identify your product’s right target audience, understand their needs and approach them in the right channels.


Tietokone kuulokkeet

Why 2 hats?

I’m interested in a lot of things. They complement each other.

Regulation expert who gets business. Marketer who knows how to write. Writer who understands marketing. Business developer who’s not taken aback by requirements, needs and expectations.


How can I understand what’s on your mind?

As a regulatory manager, I developed medical device manufacturers’ (EU MDD I-III and US FDA I-II) regulatory affairs for 5 years. For example I planned, led and implemented MDD -> MDR transformations. Nowadays I help medical device companies as an independent consultant.

As a technical copywriter and writer, I created commercial texts in English for global tech companies’ consumer audience and tech specialists for 10 years.

I’ve studied languages, coding languages, mobile phone apps, PKI infrastructure, usability, marketing, innovation, biodegradable implants, active medical devices, directives, regulations and standards (and not only from textbooks).

I’ve worked in small and midsize businesses, world-class corporations, plastics, glass, metals, chemical and technology industries.

That’s how I’ll understand you.


About my background…

I’m from Ylöjärvi, which is in western Finland in Pirkanmaa region. I studied a master’s degree in English in Jyväskylä, which is located in central Finland. Currently I live in Nokia (back to my Pirkanmaa roots) with my family.

In autumn 2020 I started my own business, because I want to help medtech and other tech companies with things I care and am excited about.

Things that the companies most likely cannot do by themselves, they want to do faster, or they want to do differently.

I want to use my competence on my own terms:

I have time for my clients.

I do my work carefully and in agreed schedule.

I use all my experience, know-how and creativity to find the best solution for my clients.


Imagine.

Less headache. Less stress.

More customers. More bottom line.

More time for yourself, family, hobbies.

Are you ready for it?


Services

Idea_ikoni

Regulatory Consulting

Regulatory strategy

Technical documentation

ISO 14971 risk management

Clinical evaluation

Post-market surveillance

Instructions for use and other labelling

Eudamed

UDI

Working with notified bodies

Support for distributors and importers

Incident handling

Developing ISO 13485 quality management system

Idea_ikoni

Marketing Consulting

Marketing strategy

Corporate social responsibility analysis

Trend analysis

Brand analysis

Marketing and sales plans

Content strategy

Blog posts

Website content

Newsletters

White papers

Case studies

Developing company’s tone of voice


I’d be happy to work with you both on single assignments and in long-term partnerships.

I provide both high-level consultation and practical hands-on execution of tasks. You decide which one you want.

I can start from scratch, or work on what you have.

Although I usually work remotely in Nokia, it’s no problem travelling if needed.

Examples how I’ve helped my clients

Created a tailored EU MDR transition project plan for a medical device manufacturer. I supported and followed up on the project progress regularly. I implemented the technical documentation update according to the new regulation and latest standards, as well as guided them on getting their QMS up to speed. As a result, the manufacturer was able to issue EU MDR Declaration of Conformity for their medical devices on schedule, and the sales of the devices continued without interruptions or delays.

Gave medical device manufacturers, distributors and importers advice on understanding the EU MDR requirements. Consequently, they could focus their time and resources on doing the right things and avoid going into the wrong (and probably expensive) direction.

Created and updated company website content in Finnish, Swedish and English to meet target group’s needs and industry requirements.

Designed a marketing plan for a new product. The plan took the company brand and solving customers’ challenges and problems into account.


Blog posts in English

Do you know these 5 MDR lessons learned?

10 Things US Medical Device Manufacturers Need To Know About Getting Their Devices To The Finnish Market

How To Get Your Business Off The Ground – 6 Lessons From My First Year As An Entrepreneur

Easy Ways To Have Better EU MDR Conversations with You Customers

Improve your EU MDR readiness in 2021 with these 5 still relevant EU MDR webinars from 2020

Medtech and Circular Economy Have More in Common Than You Think (And Why You Should Give a Damn)

Warning: Don’t Forget These EU MDR Details

Regulatory management in health tech: 5 ways it makes your business smarter

Tervetuloa/Welcome

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