Medical device regulatory expert, writer and marketer

Intended for medtech companies and organisations to

  • prevent costly, time-consuming regulatory confusion
  • improve the designing of engaging stakeholder texts
  • make it easier to stand out through value and benefit

Have you noticed any of the following symptoms?

Higher blood pressure when trying to keep up with the requirements, guidances and interpretations of the medical device regulation (MDR).

Shortness of breath as you strive to produce technical documents at the level required by the notified bodies and authorities to approve the sale of your devices.

Discomfort while attempting to write an engaging pitch or other captivating text to your stakeholder.

Difficulties seeing clearly how you stand out from your competitors or how you could look interesting to your target audience.

If even one sounded familiar, keep on reading.

I hear you.

I’ve worked for medical device manufacturers and as an independent expert for a total of seven years.

I know the expectations and challenges of the environment, where professionals like you and your team work hard every day.

Sometimes, when trying to reach the end of your to-do list or meet your deadlines in time, you may feel like you could use an extra pair of hands, without increasing the headcount.

And not just anybody’s hands but

a professional’s

who

understands the industry’s regulatory requirements

can create texts that work for your purpose

gets business

(in addition to keeping you up to date and delivering what’s promised when promised).

Examples of my blog posts

What benefits would I bring to you?

As a regulatory expert

I’d help you to understand what legislation such as the MDR means to you and prepare for the regulatory red tape developing on the horizon. By doing so, we make patient and user safety better, your market entry quicker and your business risks lower.

As a writer

I’d step up the translating of technical information into clear and interesting messages for the target audience. That would help you to reach essential supportive pillars needed in your operations and make your reliability and credibility stronger.

As a marketer

I’d complement the sales pitches of your technical solution with the value and benefit your target group will get. This would improve your visibility and pull your target audience to you.

Don’t take just my word for it.

A few quotes from my clients’ feedback:

In addition to regulatory competence, Tiina’s experience, marketing skills and language skills made an impact.

– Niko Vuorenoja, CEO, Pensi Rescue Oy

”With Tiina’s help we got a clear picture of the MDR requirements.”

– Susanna Vaismaa, Quality Manager, Frescon Oy

”The project was handled efficiently and we were happy with the end result.”

– Pasi Pulkkinen, CEO, RamonEdge Oy

Hi, I’m Tiina Tyni

I support medtech companies and organisations in regulatory, writing and marketing, so that they can efficiently develop and commercialise solutions which improve health and care.

MY STORY

I started my own company Tmi Tiina Tyni in 2020, after I had worked for five years for medical device manufacturers as a regulatory affairs manager.

During those five years I had become familiar with

EU and US medical device legislation (MDD, MDR, 21 CFR 800-), guidances (e.g. Meddev, MDCG) and standards (e.g. ISO 14971, ISO 13485)

Writing technical documentation (e.g. clinical evaluation, risk management), CE-mark and 510(k) submissions and stakeholder communication

Regulatory strategies, portfolio strategies, commercialisation and marketing claims

Cooperation with notified bodies, authorities, customers and other stakeholders

Medical device types from the highest to lowest risk class

I learned for example how manufacturers should navigate the regulatory red tape, while strengthening patient and user safety, and how documents, submissions and other texts should be structured so that their target group would react to them as intended.

FROM 2020 ONWARD

In my own company I’ve continued and deepened working on the same matters.

I’m specialised in helping companies and organisations transfer to the new medical devices regulation (EU) 2017/745, also known as the MDR.


I took MDR seriously as soon as it was published in 2017. I’m all the time keeping an eye on when the supporting MDCG guidances and standards are coming out, following news announcements and industry discussions, as well as taking trainings, so that I have the latest info to help my clients.

There are many opportunities embedded in the MDR, but the MDR is also causing a lot of extra work for many companies and organisations. It’s important to me that I can use my expertise to make it easier for them to handle the new regulatory red tape and protect patient and user safety.

SO THAT YOU WOULDN’T THINK I MADE THIS UP

”Tiina has a strong MDR expertise and competence. Tiina can explain even complex matters clearly.

Tiina was also able to create and update needed parts independently by using the existing information. This showed to us as significant cost and time savings for example in technical documentation and instructions for use updates, because Tiina could produce complete solutions on her own, which we then went over together.

In addition to regulatory competence, Tiina’s experience, marketing skills and language skills made an impact. The competence really isn’t limited to just MDR regulatory, but rather she has an understanding of many topics.

I look forward to continuing our cooperation for example when mapping out new market areas”

– Niko Vuorenoja, CEO, Pensi Rescue Oy

”When preparing to transfer our devices to medical device regulation (MDR), we wanted to get a better understanding of the new requirements and evaluate the need to update documents.

With Tiina’s help we got a clear picture of the MDR requirements and we did the Eudamed registrations. We also drafted risk management and technical file updates. In addition, Tiina helped us to solve quality and regulatory issues that came up.

Because of Tiina’s background, we expected her to have a professional way of working. The project was taken care of efficiently and flexibly.”

– Susanna Vaismaa, Quality Manager, Frescon Oy

”With Tiina’s help we were able to create a user-friendly instructions for use, which took for example safety and recycling requirements clearly into account. We can use the instructions in many ways in our product’s marketing, for example in the sales package and on the website.

Because of Tiina’s background, we were expecting her to have a precise and punctual way of working. The project was handled efficiently and we were happy with the end result.”

– Pasi Pulkkinen, CEO, RamonEdge Oy

5 SPECIAL FACTS ABOUT ME

1

Health care organisation background

My first real job was with a health care non-governmental organisation – Finnish Diabetes Association.

As the managing director’s right hand, I learned to make important documents presentable.

As one of the people translating diabetes materials, I contributed to the international breakthrough of Finnish diabetes prevention and care.

2

B2C and B2B tech writer

I worked for a total of 10 years in Nokia and Microsoft.

As English copywriter, I turned the technical information of mobile apps into such a form in English that it met the strict brand guidelines and made the use of the smart phone easy to ordinary consumers.

As technical writer, I made sure that cybersecurity specialists had the documents, content and communication channels they needed in their work promptly at hand. Diving into information security architecture stretched my technical comfort zone so much, that since then absorbing anything technical has not made my head spin.

3

Familiar with scientific style

Through my Master of Arts degree and higher level studies in marketing, I understand the scientific way of thinking, researching and writing.

It’s helpful when I’m for example working on clinical evaluations.

I know how to use different databases, analyse scientific texts and create clear, well-grounded texts for the readers.

4

Medical device and practice knowledge

During seven years in medtech, I’ve become familiar with many different devices: from the highest risk class implants to lowest risk class patient support devices.

At the same time, I’ve got to know clinical practices relevant for the devices.

I can take them in through risk management and the state of the art.

5

Digital skills

Digitalisation is not only the future of medtech, but also a way to help companies and organisations stand out and draw attention to them.

I know how to for example put together a website (like the one you’re reading now), use visual content tools and write blog posts.

Maybe I could help you too if you’re investing in digital solutions.

OTHER

I live with my family in Nokia, Finland.

When my laptop lid is closed, you can find me in jogging paths, dreaming of making a comeback as a footballer, or taking photos of my home town to my @ihastuttavanokia Instagram account.

INTERESTED?

How can I get ahold of Tiina?

Services

Regulatory

Regulatory strategy

Technical documentation

ISO 14971 risk management

Clinical evaluation

Post-market surveillance

Instructions for use and other labelling

UDI and Eudamed

Working with notified bodies

Support for distributors and importers

Incident handling

Developing ISO 13485 quality management system

Due diligence checks

Writing and marketing

Technical documents

Technical files

Website content

Blog posts

Marketing strategy

Analyses (e.g. brand, trends)

Marketing and sales plans

Content strategy

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 working on the tasks. You decide which one you want.

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

I live and work in Nokia, Finland, but most of the people I work with are based elsewhere in Finland, and more and more abroad too.

INTERESTED?

How can I get ahold of Tiina?