Our biocompatibility support services
in medical device
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.
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.
Toxi Plan’s strengths in medical device biocompatibility
At Toxi Plan, we assist medical device manufacturers in compiling robust, MDR-compliant, and scientifically defensible biocompatibility dossiers.
Our strength lies in the quality of our scientific arguments. Compliance depends not only on the testing performed but also on the ability to demonstrate—in a structured and well-justified manner—that the biological evaluation is relevant and sufficient. We develop solid rationales to define an appropriate strategy, justify the testing actually required, interpret toxicological data (TRA), and consolidate Biological Evaluation Plans (BEP) and Reports (BER).
Our support extends beyond the mere delivery of documents. In the event of an audit, observations from Notified Bodies, or non-conformities regarding the sections we authored, we remain available to analyze comments, strengthen the scientific rationale, and formulate clear, defensible responses. This responsiveness facilitates smoother interactions with auditors, secures the regulatory dossier, and minimizes delays in bringing products to market.
— 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 medical devices
All medical devices entering the EU market require a Technical File. This file provides information about the design, manufacturing, and operation of your medical device. It is intended to demonstrate that your device conforms to regulatory requirements.
Toxi Plan is your trusted partner in satisfying all thoses previous important steps!
"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.”
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