Expert Support with Biocompatibility Testing for Medical Devices Globally
Comprehensive biological safety evaluations and toxicological risk assessments to ensure regulatory compliance and patient safety throughout your device lifecycle
Biological Risk Assessment Medical Device Experts
Broad Range of Expertise Areas
NAMs, Nanomaterials, Toxicology, Implants, Wound-healing, Substance-based, Biocompatibility, ISO10993, ISO 18562, ISO7405
Biological Evaluations Contributed to
Toxicological Risk Assessments Completed
What Clients Say
"We are delighted with the comprehensive support provided by Veranex in crafting our Biological Evaluation Report for our glaucoma implants. Their expertise in this specialized field was instrumental in navigating the complexities of the topic. We greatly appreciate Veranex's contribution to the success of our project."
Constantinos Stergiopulos, Chief Technical Officer – Rheon Medical SA
What Clients Say
"Since the early stages of development of our artificial heart valve, we have been supported by Veranex for our biological risk assessment. They have provided us with in-depth knowledge of regulations, a pragmatic approach and a responsiveness adapted to start-ups. Their inputs are clear and well-structured. We found in Veranex not just a subcontractor but a true partner. As we move into the clinical phase, we're confident they'll support us right through to market entry."
Pomme Boissier, Quality, Regulatory and Clinical Affairs Manager – Novostia SA
What Clients Say
"I have been working with Veranex for a few years now. The Veranex team has supported me in the biological evaluations of different types of dental medical devices, both for short and long-term contact. What I appreciate the most is the competence, flexibility, and the pragmatic problem-solving approach."
Sabrina Buchini, PhD, Biological Safety Manager – Dentsply Sirona
From Material Guidance to Regulatory Approval
We support biocompatibility testing for medical devices by following a systematic approach designed to ensure regulatory compliance while optimizing your development timeline. We provide comprehensive biological risk assessment medical device evaluations and toxicological risk assessment medical device services throughout your entire product lifecycle.
Our services are strategically organized around the key phases of medical device development, ensuring you receive the right expertise at the right time to maximize efficiency and minimize regulatory risk.
During the early design phases, making informed material and design decisions with biocompatibility input will prevent costly issues later and ensure alignment with functional performance needs as well. Our experts integrate with our design teams to provide foundational guidance to set your project on the right path from day one:
- Material Guidance and Selection
- Initial Risk Identification
- Biocompatibility Strategy Development
- Material Characterization Planning
As your device concept becomes tangible, we help establish comprehensive testing strategies and evaluation frameworks that align with regulatory expectations and your development timeline.
- Biological Evaluation Plan (BEP) Development
- Testing Strategy Definition
- Laboratory Partner Coordination
- Prototype Safety Assessment
This critical phase requires rigorous evaluation and documentation to demonstrate biological safety. Our team ensures thorough assessment across all relevant ISO 10993 endpoints while preparing robust regulatory documentation.
- Biological Evaluation Report (BER) Preparation
- Toxicological Risk Assessment
- ISO 10993 Endpoint Evaluation
- Chemical Characterization Support
- Pathology Laboratory and Services
Successful regulatory approval depends on clear communication and comprehensive documentation. We serve as your expert partner in navigating complex regulatory interactions and submission requirements.
- FDA and Notified Body Communication Support
- Regulatory Documentation Preparation
- Deficiency Letter Response Support
- Global Submission Strategy
Biocompatibility responsibilities continue throughout your device's commercial life. We provide ongoing support for manufacturing changes, lifecycle management, and continuous compliance requirements.
- Change Control Documentation
- Updated Biological Risk Assessments
- Reprocessing and Sterilization Guidance
- Training and Educational Programs
Related Articles
Latest Blog Entries
Meet the Team
Meet Your Biocompatibility and Toxicology Experts
Our multidisciplinary team of European Registered Toxicologists, PhD scientists, and biomedical engineers brings deep expertise in toxicology, polymer technology, molecular biology, material science, and regulatory affairs. Combined with extensive medical device industry experience, this diverse knowledge base enables us to support biological evaluations across all risk classes and development phases worldwide.
Monica Grekula
Sr Director, Biocompatibility and Toxicology
Monica Grekula serves as Senior Director at Veranex Sweden AB in Stockholm, where she leads the biological safety and toxicology team with over 25 years of expertise in the medical device industry. She specializes in biological evaluations across all development phases from a global perspective, covering Class I-III devices and combination products, with comprehensive experience working with various notified bodies and national regulatory authorities. Monica holds a Master of Science in Pharmacy and a Master of Science in Applied Toxicology, and is certified as a European Registered Toxicologist (ERT). She has been an active member of ISO/TC194 since 2006 and has initiated and organized five international conferences dedicated to the biological evaluation of medical devices, demonstrating her leadership in advancing industry standards and knowledge sharing.
Lina Burman
Sr Manager, Biocompatibility and Toxicology
Lina Burman is a senior manager in biocompatibility and toxicology at Veranex. Her PhD in polymer chemistry, focusing on chemical analyses and degradation behavior of polymers, has been a valuable foundation for understanding exposure considerations for medical devices. During her over 15 years of working with biological evaluations and toxicological risk assessments of medical devices, she has been actively involved in the standardization committee ISO/TC 194 (ISO 10993 series) to ensure compliance with current regulatory requirements and, importantly, to influence the development of better methods to assure safe products on the market. Lina has deep expertise in the evaluation of breathing gas pathway devices with 10 years of experience in this industry area and has participated in the development of the ISO 18562 series since its inception.
Carl-Johan Zettervall
Sr Manager, Biocompatibility and Toxicology
Carl-Johan Zettervall is a Senior Consultant in biological safety and toxicology at Veranex in Stockholm, Sweden, with a PhD in cellular and molecular biology and certification as a European Registered Toxicologist (ERT). He brings a professional background in safety assessments of pharmaceuticals and biocompatibility of medical devices, with more than 12 years focused on medical device consulting. His expertise encompasses risk assessments and preparation of regulatory submissions for global markets, particularly the US and European markets, across a wide range of medical device classes. Increasingly, Carl-Johan specializes in toxicological risk assessments for devices where chemical data is available, utilizing extractables and leachables (E/L) analysis and employing various methodologies to assess biocompatibility, including read-across approaches and in silico computational tools.
Real-World Impact Across Device Categories
Successful Case Studies of Biological and Toxicological Risk Assessments for Medical Devices
Case Study
Situation
With the transition from Medical Device Directive 93/42/EEC to Medical Device Regulation 2017/745, the client needed support to update their technical documentation, including revisiting their biological risk assessments (BRAs), ensuring the validity of existing tests, planning additional tests, and analyzing the results.
Successes
The Veranex team has provided reliable, consistent, and continuous support over a number of years. Over the course of the support, a total of more than 40 products have been assessed. Following our strategic approach, some of the client’s devices went through the CE certification process and are now compliant with the latest regulations, allowing them to remain available on the EU market.Services by Veranex
The biological safety team at Veranex provided continuous support for updating and writing biological risk assessments for a large number of medical products. The work started with an update to the client’s internal biological safety process (SOP) and template for the redaction of BRAs. Then we assessed the biological safety of various devices. We also provided the necessary training on biocompatibility to ensure the client had a thorough understanding of deliverables and was able to answer questions from notified bodies.Discover More
Related Services at Veranex
Product Development & Engineering
Integrate biocompatibility considerations early in your design process for optimal outcomes.

Quality Consulting
Establish robust quality management systems that integrate seamlessly with your biocompatibility programs.

Regulatory Consulting
Navigate complex regulatory pathways with expert guidance on FDA and MDR submissions.

Medical Device CRO
Design and execute clinical studies that support your biocompatibility findings with real-world evidence.

Transform Your Medical Device Biological Risk Assessment Strategy
Our specialized team delivers comprehensive biocompatibility evaluations that satisfy regulatory requirements and accelerate your path to market. Let's discuss your specific testing needs.



