Medical devices MDR regulatory specialist
Intended for medical devices companies
I help you to
- understand regulatory requirements (especially the MDR) in practice
- write the necessary technical documentation
- achieve and maintain CE marking for your medical devices
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 Devices Regulation (MDR).
Shortness of breath as you strive to produce technical documents at the level required by the notified bodies and authorities.
Headache when trying to get your device through the red tape.
Difficulties seeing clearly how to navigate the growing regulatory complexity.
If even one sounded familiar, keep on reading.
I hear you.
I’ve worked for medical device manufacturers and as an independent expert a total of 10 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?
I’d help you understand what legislation such as the MDR means for you.
We’d also prepare for the regulatory red tape developing on the horizon.
We’d strengthen patient and user safety, accelerate market entry, and lower business risks.
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 medical device companies with regulatory matters (especially the MDR), so they can develop and commercialise solutions which are regulatory compliant, save lives, and protect patient and user health.
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 they would benefit the target group.
FROM 2020 ONWARD
In my own company I’ve continued and deepened working on the same matters.
I’m specialised in helping companies transition to the 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 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.
It’s important to me to use my expertise to help them handle the 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
”Thank you for the pleasant and professional collaboration and your support to our customers and wish you all the best in your further career”
– Jan van Lochem, CEO, Qserve Consultancy B.V.
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 converted the technical information of mobile apps in English into texts that met the brand guidelines and helped ordinary consumers use the devices easily.
As technical writer, I made sure that cybersecurity specialists had the documents, content and communication channels they needed available for them. 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 10 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 make companies look more interesting.
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 is closed, you can find me exercising in the gym, dreaming of making a comeback in football, or volunteering as a book buddy.
INTERESTED?
How can I get in touch with Tiina?
Tiina Tyni’s services
Medical Devices Regulation (MDR)
Regulatory strategy
Writing technical documentation
ISO 14971 risk management
Clinical evaluation
Post-market surveillance
Handling and reporting serious incidents
Instructions for use and other labelling
UDI and EUDAMED registrations
Working with notified bodies and competent authorities
Supporting distributors and importers
Developing ISO 13485 quality management system
Due diligence checks
Other EU legislation that may affect medical devices (e.g. AI Act, Battery Regulation)
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 in touch with Tiina?
Blog posts in English
Understanding the value of regulatory literacy in medical devices
Why legacy devices have struggled under the MDR, and what AI developers can learn from it?
Important MDR dates and deadlines for 2025
GSPR vs. GPSR: 10 things medical device companies need to know
7 quotes from 2023 to guide you on the medtech market
Guest blog – How regulatory professionals can keep up to date with growing regulatory complexity
Here’s why medical device manufacturers and healthcare professionals should come together more
Do you know these 5 MDR lessons learned?
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 Your 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
