Biocompatibility
Services

“I can prepare Biological Evaluation Plan 
and Report for your medical device”

Biocompatibility
Services

“I can prepare Biological Evaluation Plan 
and Report for your medical device”

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.

Testimonials

Contact

Let’s talk about your next project or training need.

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