Getting your medical device approved shouldn’t take years of trial and error

I help early-stage MedTech founders get a clear EU MDR, UKCA and/or FDA regulatory strategy in just 30 days so they can move forward with confidence, reduce delays and get to market faster

The problem:
Many founders are unsure which pathway applies, what documents are required or how to avoid months of regulatory back-and-forth. Without a clear plan, they risk burning runway, missing opportunities and losing investor confidence

How I help:

- Map the exact regulatory pathway (CE, UKCA, 510(k), De Novo, PMA)
- Define intended use & classification to align with regulators
- Build a step-by-step submission readiness plan
- Provide hands-on support for technical documentation, QMS & audits
- Guide devices including SaMD, AI/ML, hardware and IVDs through IEC 62304, IEC 82304, applicable ISO standards and emerging AI frameworks

Full capabilities:

Regulatory consulting: CE marking under MDR/IVDR, UKCA certification, FDA pathways (510(k), De Novo, PMA). PRRC & UKRP services. Gap assessments, submission support & strategic planning

Quality assurance: Implement & remediate QMS to ISO 13485 & MDSAP. Lead audits, manage CAPAs & complaints, support risk management (ISO 14971), process validation (IQ, OQ, PQ) & sterilisation (ISO 11607). Certified ISO 13485 Lead Auditor (CQI/IRCA)

Digital health / SaMD: Compliance with IEC 62304, IEC 82304 & AI/ML frameworks. Software validation & CSV for regulatory alignment

eQMS platforms: Implement Greenlight Guru, Qualio, MasterControl, JIRA & Confluence, with CSV to ensure audit readiness

Due diligence: Regulatory & QMS assessments for investors, accelerators & M&A. Identify red flags in technical documentation & submissions before they become costly

Training & microconsulting: For teams & founders building internal capability. CQI/IRCA-registered tutor for MDR, IVDR, ISO 13485, ISO 14971 & MDSAP

I’m a startup advisor and competition judge for MedTech Innovator, Springboard Enterprises and MassChallenge. As a trainer and host of The MedTech Podcast, I work with founders, investors and accelerators worldwide to deliver regulatory clarity and practical strategies

I combine regulatory expertise with a practical, execution-focused mindset. Clients value my ability to cut through complexity, reduce time to market, pass audits and scale confidently, whether launching a first product or expanding internationally

If you’re navigating regulatory uncertainty or preparing for growth, let’s connect

🎙️ The MedTech Podcast | 📺 YouTube: @KarandeepBadwal

Karandeep Badwal

Mastermind Translations Ltd

As the Director of Mastermind Translations Ltd, I spearhead our mission to deliver premium translation services tailored specifically for the life sciences industries. Our expertise spans a diverse range of documents in the fields of human and veterinary medicine, pharmaceuticals, clinical research, biotechnology, and medical devices.

📈Key Responsibilities:

➡️ Client Liaison: Cultivating and maintaining robust client relationships to fully comprehend and fulfill their unique translation needs.
➡️ Project Management: Steering projects from initial consultation through to final delivery, ensuring adherence to deadlines and maintaining the highest quality standards.
➡️ Team Leadership: Providing strategic direction and linguistic expertise to our team, fostering a culture of excellence and continuous improvement.
➡️ Quality Assurance: Implementing rigorous quality control processes to guarantee accuracy, regulatory compliance, and consistency in all translations.
➡️ Business Development: Identifying and pursuing new business opportunities to drive growth and expand our client base within the life sciences sector.

Under my leadership, Mastermind Translations has grown to become a trusted partner for high-profile clients like medac, HIPRA, and Pal International, renowned for our commitment to delivering value-added, top-quality translation services in the life sciences.

Discover more about our services at https://mastermindtranslations.co.uk/.

Director

London Metropolitan University

Guest Lecturer on the Medical Translation Module

As a guest lecturer at London Metropolitan University, I deliver engaging and insightful lectures on the medical translation module for MA and BA students. My lectures are designed to equip students with a deep understanding of current trends in life science translation and provide practical guidance on how to pursue a successful career in this specialised field.

💡Key Topics Covered:

➡️ Current Trends in Life Science Translation: Exploring the latest developments and innovations in the translation of medical, pharmaceutical, and medtech content.
➡️ Career Pathways: Offering valuable insights and strategies for students aspiring to build a career in life science translation, including necessary skills, qualifications, and industry demands.
➡️Practical Experience: Facilitating an annual internship program at Mastermind Translations for MA students, allowing them to gain hands-on experience in life science translation project management and understand the intricacies of working in a professional translation environment.

Through my lectures, I aim to inspire and prepare the next generation of translators to excel in the dynamic and critical field of life science translation.

Guest Lecturer

ITI Medical and Pharmaceutical Network

In my role as MedNet's Deputy Coordinator, I played a pivotal role in orchestrating the activities of a dynamic group of over 250 professional translators specialising in medical, pharmaceutical, and related fields. This network, a part of the Institute of Translation and Interpreting, brings together experts from across the globe to share knowledge and advance our profession.

🌐Key Responsibilities:

➡️Member Support: Providing comprehensive support to network members, ensuring they have access to the resources and guidance needed to excel in their work.
➡️ Workshop Organisation: Coordinating and hosting workshops on diverse medical subjects both within the UK and internationally, fostering professional development and knowledge sharing.
➡️ CPD Event Planning: Strategically planning Continuing Professional Development (CPD) events to keep members abreast of the latest industry trends and best practices.
➡️ Representation: Actively representing and promoting the Network at various UK and international events, enhancing our visibility and influence within the translation and medical communities.
➡️ Professional Liaison: Building and maintaining strong relationships with professionals from both the medical and translation industries, facilitating valuable collaborations.
➡️ Committee Assistance: Supporting the Network Coordinator and the Committee in their duties, ensuring smooth operation and the successful achievement of our collective goals.

For more information about the Network, please visit the Institute of Translation and Interpreting Medical and Pharmaceutical Network https://www.itimedical.co.uk.

Deputy Coordinator

Mastermind Translations

In this role, I provided premium translation and other linguistic services to clients operating in the medical, pharmaceutical, medtech, and biotechnology sectors. My work focused on ensuring accuracy, clarity, and compliance in all translations, delivering high-quality linguistic solutions tailored to the specific needs of the life science industries.

👩‍💻Key Responsibilities:

➡️ Specialised Translation: Translating complex medical, pharmaceutical, and technical documents from English, French, and Dutch into Polish, ensuring precision and adherence to industry standards.
➡️ Document Types: Handling a diverse range of documents, including clinical trial protocols, patent applications, patient information leaflets, regulatory submissions, technical manuals, research articles, and marketing materials.
➡️ Quality Assurance: Implementing rigorous quality control measures to ensure the highest level of accuracy and consistency in all translations, meeting the stringent requirements of the life sciences sector.
➡️Terminology Management: Developing and maintaining comprehensive terminology databases to support consistency and accuracy across all projects.
➡️Client Communication: Liaising directly with clients to understand their specific needs and deliver customised translation solutions that meet their exact requirements.
➡️Confidentiality and Compliance: Ensuring all translations adhere to regulatory guidelines and maintaining strict confidentiality of sensitive client information.
➡️Continuous Learning: Staying up-to-date with the latest developments in the life sciences and translation industries to provide informed and relevant translation services.

By consistently delivering high-quality translations and maintaining strong client relationships, I have built a reputation for reliability and excellence in the life sciences translation field.

Medical, Pharmaceutical and Technical Translator (EN, FR, NL > PL)

European Parliament

As a translation trainee at the European Parliament, I gained invaluable experience translating a diverse array of official documents. My role involved translating from English, Dutch, and French into Polish, covering a wide spectrum of European affairs.

🇪🇺 Key Responsibilities:

➡️ Translation:
  - Translating official documents from English, Dutch, German and French into Polish across various domains, including EU institutions, justice and citizenship, external relations, agriculture and fisheries, budget, culture and education, economic and monetary affairs, employment, social affairs, internal market, industry, regions, transport, health, and environment.
  - Types of documents translated: official letters, public agendas, meeting agendas, resolutions, reports, petitions, opinions, written declarations and questions, press articles, website content, notices to MEPs, and parliamentary amendments.

➡️ Document Revision:
  - Revising documents translated from English, Dutch, German and French to ensure accuracy, consistency, and adherence to the European Parliament’s standards.

➡️Terminology Management:
  - Managing and maintaining terminology databases to ensure consistency and precision in translations, utilizing tools such as IATE, Euramis, FullDoc, and EurLEX.

➡️Site Visits:
Participated in visits to various EU organisations, including:
    - The European Parliament in Strasbourg
    - The Council of Europe in Strasbourg
    - The European Commission in Brussels
    - The Court of Justice of the European Union in Luxembourg
    - The European Court of Human Rights in Strasbourg

Through this role, I gained a deep understanding of translating high-stakes documents for influential international institutions, honing my skills in precision, regulatory compliance, and multilingual communication. Visits to various key EU institutions provided first-hand insights into their operations and the context of our translations.

Translation Trainee (EN, NL, FR > PL)

Welcome to my profile!

Are you seeking top-tier translation services for your critical life science content? Look no further. At Mastermind Translations, we specialise in linguistic solutions tailored to the life science industries.

Why Choose Us?

🔬 Expertise: Founded in 2015, Mastermind Translations combines extensive life science expertise with deep industry knowledge to ensure your documents are translated accurately and on time.
📈 Proven Success: With over 600 satisfied clients and nearly 5,000 completed projects, our track record speaks volumes about our commitment to excellence.
💡 Core Values: Quality, Diligence, Reliability, Integrity, Dedication. These principles guide everything we do, ensuring your translation needs are met with the highest standards.

🔍 Our Specialisations Include:
- Human & Veterinary Medicine
- Pharmaceuticals
- Clinical Research
- Biotechnology
- Chemical Engineering
- Medical Devices

📨 Let’s connect and explore how we can support your translation needs. Reach out at kasia@mastermindtranslations.co.uk.

Katarzyna Slobodzian-Taylor

𝗔 𝘀𝗶𝗻𝗴𝗹𝗲 𝘁𝗿𝗮𝗻𝘀𝗹𝗮𝘁𝗶𝗼𝗻 𝗲𝗿𝗿𝗼𝗿 𝗶𝗻 𝗮𝗻 𝗜𝗙𝗨 𝗰𝗮𝗻 𝘁𝗿𝗶𝗴𝗴𝗲𝗿 𝗮 𝗙𝗶𝗲𝗹𝗱 𝗦𝗮𝗳𝗲𝘁𝘆 𝗡𝗼𝘁𝗶𝗰𝗲. Swipe through the slides below for a real MedTech case where this actually happened. 

During our workshop at #MedInTechs in Paris last week, Anne Neto (Diamantidis) and I discussed several real examples where issues in translated medical device product information required regulatory corrective action.

Here is one case.

A medical device manufacturer had to issue a 𝗙𝗶𝗲𝗹𝗱 𝗦𝗮𝗳𝗲𝘁𝘆 𝗡𝗼𝘁𝗶𝗰𝗲 (𝗙𝗦𝗡) after an error appeared in translated IFUs.

In several language versions of the IFU, the maximum implantation time was stated as “30 months” instead of “30 days.”

The device concerned was the PU-R Double Loop Ureteral Stent Kit, manufactured by Coloplast A/S, and the case was handled by ANSM (France).

Corrective action included issuing an FSN and distributing corrected IFU translations.

Cases like this rarely stem from vocabulary alone. More often, they reflect weaknesses in the translation workflow and quality control process.

Under the EU MDR and IVDR, the IFU forms part of the 𝗿𝗲𝗴𝘂𝗹𝗮𝘁𝗲𝗱 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 𝘀𝘂𝗽𝗽𝗹𝗶𝗲𝗱 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝗱𝗲𝘃𝗶𝗰𝗲 𝘂𝗻𝗱𝗲𝗿 𝗔𝗻𝗻𝗲𝘅 𝗜 𝗿𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀. Translation errors in IFUs are therefore 𝘯𝘰𝘵 simply linguistic issues but can quickly escalate into regulatory compliance issues.

𝗖𝗮𝘀𝗲𝘀 𝗹𝗶𝗸𝗲 𝘁𝗵𝗶𝘀 𝗿𝗮𝗶𝘀𝗲 𝗮𝗻 𝗶𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗾𝘂𝗲𝘀𝘁𝗶𝗼𝗻: 𝗵𝗼𝘄 𝗿𝗼𝗯𝘂𝘀𝘁 𝗶𝘀 𝘁𝗵𝗲 𝘁𝗿𝗮𝗻𝘀𝗹𝗮𝘁𝗶𝗼𝗻 𝘄𝗼𝗿𝗸𝗳𝗹𝗼𝘄 𝗯𝗲𝗵𝗶𝗻𝗱 𝘆𝗼𝘂𝗿 𝗽𝗿𝗼𝗱𝘂𝗰𝘁 𝗶𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻?

Muriel Benitah Julien Schemoul Anthony Maghlaoui Aleksandra Izabela Kobyłecka Ewelina Katarzyna Limas Douglas Galloway Cécile Chevalier Guillaume Calmon Setan B. Diane Cherrier Marie-Pierre Gérard Samuel P. Emma Pages-Bouic

Katarzyna E Slobodzian-Taylor

Supporting Life Science Organisations with UK, EU & Global Translation Needs | ISO-Certified Workflows for Pharma, Biotech & MedTech | Trusted Partner for Mission-Critical Projects | Language Risk in Life Sciences

WHEN TRANSLATION BECOMES A REGULATORY INCIDENT

𝗠𝗲𝗱𝗧𝗲𝗰𝗵 𝘀𝘁𝗮𝗿𝘁-𝘂𝗽 𝗹𝗼𝘀𝘁 𝗶𝗻 𝘁𝗿𝗮𝗻𝘀𝗹𝗮𝘁𝗶𝗼𝗻? Here's your survival guide.

International expansion is a strategic priority for most MedTech companies. Yet for many, language is still treated as an operational afterthought. This is where real issues quietly accumulate across labelling, IFUs, GUIs, regulatory documentation and promotional materials.

At MedInTechs 2026 in Paris, I'm delighted to be speaking alongside Anne Neto (Diamantidis) of eLoc Smart Solutions GmbH, delivering a practical session:

“𝗟𝗼𝘀𝘁 𝗶𝗻 𝗧𝗿𝗮𝗻𝘀𝗹𝗮𝘁𝗶𝗼𝗻 ? 𝗟𝗲 𝗴𝘂𝗶𝗱𝗲 𝗱𝗲 𝘀𝘂𝗿𝘃𝗶𝗲 𝗱𝗲𝘀 𝘀𝘁𝗮𝗿𝘁𝘂𝗽𝘀 𝘀𝗮𝗻𝘁𝗲”
📆 10 March 2026, 10:45 to 11:25 
📍 Salle Ateliers, Parc Floral de Paris
𝘓𝘪𝘯𝘬 𝘪𝘯 𝘵𝘩𝘦 𝘤𝘰𝘮𝘮𝘦𝘯𝘵𝘴

We'll explore where MedTech teams most commonly underestimate the complexity of translation and localisation, and how this leads to very real challenges in practice:

❎Product information and regulatory documentation not meeting EU MDR and IVDR requirements
❎Risks to patient safety and compromised product performance
❎Poor software usability and reduced user adoption in local markets
❎Promotional and market-facing materials undermining product positioning
❎Inconsistencies across product ranges and lifecycle updates becoming an operational burden due to weak translation management
❎Spiralling, hidden cost of “quick” language fixes

This is 𝘯𝘰𝘵 a theoretical session. We'll share concrete examples of where otherwise strong MedTech products have struggled due to translation and localisation challenges, and practical ways to build a robust language strategy for international expansion without turning language into a blocker to scale.

If you'd like to continue the conversation after the session, please do come by 𝘀𝘁𝗮𝗻𝗱 𝗖𝟮𝟯 to enjoy complimentary coffee and chocolate.

À bientôt à Paris 🇫🇷

Supporting Life Science Organisations with EU & Global Translation Needs | ISO-Certified Language Solutions Designed for Pharma, Biotech & MedTech | Trusted Partner for Mission-Critical Work | Personal Bespoke Service

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