Medical devices MDR regulatory affairs specialist, 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 a 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 eight 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 a legislation such as the MDR means to you. We’d prepare for the regulatory red tape developing on the horizon as well. By doing so, we make patient and user safety better, your market entry faster and your business risks lower.

As a writer

I’d translate the technical information into clearer and more interesting messages for the target audience. This would help you to reach essential supportive pillars needed in your operations and make your reliability and credibility stronger.

As a marketer

I’d round off your technical solution’s sales pitches with the value and benefit intended for your target group. 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:

We got concrete help and insight into how we should develop our clinical evaluation process – – Hoping we can work together again.

– Kirsti Koivulampi, Development Manager / R&D Quality Manager, HUS IT Management

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

– Niko Vuorenoja, CEO, Pensi Rescue Oy

”Thank you for the pleasant and professional collaboration and your support to our customers”

– Jan van Lochem, CEO, Qserve Consultancy B.V.

Hi, I’m Tiina Tyni

I help medtech companies and organisations with regulations (especially the MDR), writing and marketing, so 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 became 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 transition to the new medical device regulation (EU) 2017/745, also known as the MDR.


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

There are many opportunities embedded in the MDR. However, 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 help them handle the new regulatory red tape and protect patient and user safety.

SO YOU WOULDN’T THINK I MADE THIS UP

”We turned to Tiina when we needed practical help with medical device software manufactured by HUS – especially with their clinical evaluations – to implement the MDR requirements and MDCG guidances. We were familiar with the regulation already and had the clinical expertise, but as manufacturers we wanted in particular to ensure a clear and smooth workflow for conducting the clinical evaluations during the MDR transition period.

Coaching sessions with Tiina helped us to clarify the MDR and MDCG issues on the table. We got concrete help and insight into how we should develop our clinical evaluation process.

In addition, Tiina’s technical documentation skills were valuable in building an MDR and MDCG compatible clinical evaluation basis for our devices. We’re now also able to better align the demonstration of conformity with the notified body’s expectations, as Tiina gave us tips on the best practices.

Hoping we can work together again. I’ve recommended Tiina to other people too.”

– Kirsti Koivulampi, Development Manager / R&D Quality Manager, HUS IT Management

”Tiina has a strong MDR expertise and competence. She 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 affairs, 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

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 the association’s 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 smart phone use easy for ordinary consumers.

As technical writer, I made sure that cybersecurity specialists had available the documents, content and communication channels they needed. Diving into information security architecture stretched my technical comfort zone so much that absorbing anything technical since then hasn’t 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 medical device 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 eight 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’m able to 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 for example how to put together a website, use visual content tools and write blog posts. For instance, I’ve designed and coded websites (like the one you’re looking at now).

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?

Tiina Tyni’s services

Regulatory

Specialised in MDR 2017/745

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. 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 abroad.

INTERESTED?

How can I get ahold of Tiina?