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.
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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
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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.
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