Secure the biocompatibility of your medical device with the JN™ Method — Just Necessary
Book a consultation with an expert in biocompatibility
Accelerate your time to market with a targeted toxicological strategy for biocompatibility compliance with ISO 10993 and MDR requirements — without unnecessary testing.
Situation analysis
Toxi Plan analyze your situation and help you secure your biocompatibility strategy: BEP, TRA, BER and regulatory compliance.
An expert ready to listen to you
We offer a confidential 30-minute consultation to get to better understand your needs.
A recurring problem
and medical device biocompatibility services
Biocompatibility is a core regulatory requirement for medical devices under MDR and ISO 10993.
Manufacturers face complex challenges:
- Evolving regulatory expectations
- Uncertainty about which studies are truly required
- Difficulty structuring a robust Biological Evaluation Plan (BEP)
- Complex interpretation of toxicological data (TRA)
- Risk of non-conformities during notified body audits
A poorly defined strategy can lead to delays, additional costs, and regulatory uncertainty.
— PRIMARY RISK—
An unclear strategy can significantly delay your time to market and trigger additional regulatory requests.
— COST OPTIMIZATION —
A targeted strategy helps avoid unnecessary studies, thus optimizes your development resources.
The solution: the JN™ Method
— Just Necessary —
At Toxi Plan, we apply the JN™ Method, a structured scientific approach based on precision and strategic reasoning.
We analyze your medical device, materials, intended use, and available data to determine the exact level of evidence required. Not insufficient but not excessive. Just Necessary.
- Secure your biocompatibility strategy
- Build strong scientific justifications
- Avoid unnecessary studies
- Reduce development timelines
- Optimize costs by focusing only on required evidence
- Accelerate your time to market
Our expertise
and medical device biocompatibility services
Our expertise allow us to support manufacturers throughout the biological evaluation process:
- Definition of biological evaluation strategy
- Preparation and update of Biological Evaluation Plans (BEP)
- Toxicological Risk Assessments (TRA)
- Preparation of Biological Evaluation Reports (BER)
- Interpretation of chemical characterization results
- Scientific justification and argumentation
- Support during interactions with notified bodies
— END-TO-END SUPPORT —
A dedicated expert supporting you from BEP through BER, including notified body interactions.
Non-conformities:
a critical moment where our expertise makes the difference
Many manufacturers contact us following:
- A notified body non-conformity
- MDR audit observations
- Insufficient or challenged BEP, TRA, or BER
- Requests for regulatory clarification
We support you by:
- Analyzing audit observations
- Identifying gaps and root causes
- Strengthening scientific justification
- Updating documentation
- Preparing clear and defensible responses
— RAPID RESOLUTION—
Average intervention timeline needed : 1 month to secure your regulatory position. As a result, you maintain control over your timelines while ensuring regulatory compliance (More d’information.)
Our expertise in scientific argumentation
The heart of a solid biocompatibility demonstration
Compliance does not rely solely on testing, as it also depends on the strength of the scientific rationale.
In the context of biocompatibility, this approach is essential to demonstrate biological safety in a consistent and justified way.
At Toxi Plan, we build robust scientific rationales in order to structure and secure your dossier.
Thus, we:
Justify the strategy defined in the BEP
Interpret TRA results
Demonstrate biological safety in the BER
Respond effectively to notified body observations
In addition, we adapt each rationale to the expected level of evidence, so that you anticipate regulatory requirements.
You therefore strengthen your dossier’s credibility and ensure long-term compliance in terms of biocompatibility.
— KEY STRATEGIC ADVANTAGE —
We build strong, defensible scientific rationales to strengthen your dossier, ensuring you can confidently address auditors and notified bodies.
Who this is for?
Manufacturers seeking to secure compliance and accelerate time to market.
This support is designed for:
- All medical device manufacturers
- Companies in development or pre-market phases
- Teams preparing or updating BEP, TRA, or BER
- Manufacturers facing MDR or ISO 10993 requirements
- Companies addressing regulatory observations or non-conformities
"What our clients say"
Medical device manufacturers trust us to ensure their regulatory compliance!
Regulatory Affairs Pharmacist, Crossject Pharmaceutical Company
“The tasks entrusted to ToxiPlan for the preparation of our registration dossier were completed on time and with a satisfactory level of expertise. We would consider using their services again for a future update or for the development of a new project.”
Quality Director - Implantable medical device manufacturer
“We really appreciated their structured and pragmatic approach that helped us clarify our biocompatibility strategy. Our BEP and BER were accepted without additional questions from our notified body.”
Class IIa medical device company (50 employees)
“As part of our compliance with the MDR Regulation, we needed to ensure the biological evaluation of our Class IIa medical devices. We chose ToxiPlan for their competitive pricing, which allowed us to conduct tests on all our products, rather than relying solely on equivalence approaches. This strategy enabled us to compile a more comprehensive and robust biological evaluation dossier, providing greater peace of mind for the future. Beyond this, we particularly appreciated the team’s availability and responsiveness, as well as their support in understanding the reports and justifying the various regulatory elements. This greatly facilitated the creation of a clear and solid dossier, an essential component of the technical dossier for MDR certification. Today, we are MDR certified and confident about the future, knowing we can count on a reliable partner for our future testing. If we had to do it all over again, we would not hesitate to choose ToxiPlan again.” »
R&D Manager - Class IIb medical device manufacturer
“Toxi Plan interpreted our chemical characterization data and conducted the TRA with exceptional rigor. Also, their scientific justification was instrumental in obtaining regulatory acceptance.”
Technical Director - Medical device manufacturer
“Their responsiveness and expertise helped us resolve a critical regulatory situation within weeks. Furthermore, their support during notified body interactions was invaluable.”
Discuss with a Toxi Plan expert
Book a consultation with an expert in biocompatibility
Book a free consultation with our experts to secure the biocompatibility of your medical device and clarify your challenges.
This way, we analyze your situation and identify fast, practical solutions tailored to your regulatory requirements.
Credibility earned through thousands of reviews
Toxi Plan supports medical device manufacturers in securing their biocompatibility strategy, from BEP through BER.
Our differentiation:
- High responsiveness
- Pragmatic, structured approach
- Specialized expertise in medical device biocompatibility
- Strong and defensible scientific justifications
- Full support during notified body interactions
- Strategic approach optimizing timelines and resources
Toxi Plan
Medical Device Biocompatibility Experts - Architects of Scientific Evaluation Strategies - Creators of the JN™ Method - We deliver what is just necessary.
Contact Us
Address
7 Rue Benjamin Franklin, Bâtiment gauche B, ZI TRIASIS. 31140 Launaguet - France