Problem
statement
For medical device manufacturers — whether established companies with legacy products or innovative startups — navigating the complexities of biocompatibility and regulatory requirements can be overwhelming.
As the EU MDR continues to evolve and ISO 10993-1 updates are forthcoming, many organizations face challenges in ensuring their Biological Evaluation Plans/Reports (BEP/BER) are up-to-date and compliant.
If your existing devices require MDR remediation or you’re developing a new product, gaps in your evaluation strategy could hinder your ability to meet current and future regulatory requirements.
About
Marina Daineko
I’m a biocompatibility consultant with 10+ years of experience in the medical device industry.
My journey began in analytical chemistry and led me to develop biological evaluations aligned with ISO 10993 and ISO 14971.
Today, I help teams navigate global regulatory frameworks, reduce unnecessary testing, and achieve faster approvals.
Along the way, I’ve authored 15+ white papers, received a Women in Tech Award nomination, and trained professionals across Europe and beyond.
Recognitions
Recognized for advancing biocompatibility best practices worldwide:
Award Nominee
One of the top 25 MedTech Leading Voices on LinkedIn
Speaker
International conferences and medical device training programs
Trainer
Delivered comprehensive sessions on ISO 10993 in the light of FDA and EU MDR compliance
Author
15+ scientific papers
on materials science
How can
I help you?
I specialize in conducting thorough Biological Evaluation for existing medical devices, ensuring that your product’s documentation complies with ISO 10993-1 and ISO 14971.
If you’re a startup developing a new device, I’ll guide you through creating a comprehensive BEP/BER from the ground up, ensuring regulatory alignment.
Additionally, I offer consultancy on optimizing your test strategy and provide customized training to ensure your team is prepared for evolving regulations.

Services:
Biological Evaluation Plans & Reports
Personalized Training and Workshops
Analysis & Testing Strategy Optimization
Regulatory Submissions Support (EU MDR, FDA) from biological safety perspective
Gap assessment

Where
I Work
Based in Europe, collaborating with medtech companies worldwide.
Preparing your Biological Evaluation across the US (FDA), Europe (EU MDR), and Asia-Pacific regions.
