Medical Devices Regulation
From safety to performance, we support you in securing every stage of your medical device’s lifecycle. Toxi Plan: clear and reliable expertise to ensure your medical device regulatory compliance
"The problem every manufacturer of Medical Devices face"
A current problem that medical device manufacturer face is that they are required to provide a technical file that demonstrates that their product meets EU safety and performance requirements.
This file must be submitted to a Notified Body for approval. It’s also a mandatory step in acquiring the well known CE Marking.
The CE Marking is an EU health, safety, and environmental certification that allows products to be marketed in 32 countries
You’ll also need a Toxicology documentation demonstrating your medical device regulatory compliance with biological safety requirements.
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!
"The Regulatory MDR Technical File"
We know it’s complicated, so we’ve simplified it for you!
We help you to meet your market entry
Our toxicologists have assessed the toxicological and biological risks of numerous devices:
- Intracranial implants
- Devices combined with medications
- External prostheses
- Sanitary tampons
- Endotracheal tubes
- Dressings
- Dental gels
- Nasal/ear sprays
- Pain relief gels
The european regulatory framework for medical devices, as well as mentality, are evolving. Consumers want brands to consider ecotoxicological impacts throughout the entire lifecycle of healthcare products. Integrating ecotoxicology from the design and evaluation stages of your medical devices provides a strategic lever for scientific credibility with users and partners.
Our eToxiSafe ecolabel supports you with specialized ecotoxicology modules, designed to secure your regulatory assessments.
- 1. Ecotoxicological profile
- 2. Ecotoxicity tests
- 3. Ecotoxicological impact assessment
Toxicology & Regulatory
1. Biological Assessment Plan (BEP)
Toxi Plan offers regulatory consulting services to help you establish a rigorous Biosafety Assessment Plan (BSAP). We help you identify the specific tests required for your device to ensure its biocompatibility, in accordance with ISO 10993-1.
This mandatory, customized report will allow you to optimize your time and budget!
2. Literature review
Toxi Plan performs documentary analyses on similar medical devices and on the history of use of the materials of your medical device, in accordance with the ISO 10993-1:2020 standard.
3. Toxicological profiles
Toxi Plan will establish the toxicological profiles of the materials used in your medical device.
4. Study of alternative materials
In the event of a change of materials or supplier, Toxi Plan offers an equivalence study which can prove that the biological assessment is still valid/compliant.
5. Chemical Characterization (CC)
We help you define the various analytical parameters for the chemical characterization of your device (extraction solvents, toxicological thresholds, etc.), in accordance with ISO 10993-12 and 18 standards.
We offer support at every stage of the chemical characterization process through our partnerships with accredited and reliable laboratories.
6. Toxicological Risk Assessment (TRA)
Toxi Plan will analyze and provide a report on the toxicological acceptability of extractables found during the chemical characterization (CC) of your medical device, in accordance with ISO 10993-17.
7. Requests for biocompatibility testing (BC)
Our company is committed to upholding the highest ethical standards. Therefore, biocompatibility (BC) testing is conducted by external and independent laboratories, in accordance with ISO 10993.
We can provide you with a list of references.
8. Analysis of biocompatibility tests (BC)
Toxi Plan will provide you with a complete analysis and interpretation of your biocompatibility test results, in accordance with ISO 10993.
We can provide you with a list of references.
9. Contaminant Analysis
Toxi Plan identifies and characterizes the toxicological hazards of potential contaminants in your medical device (manufacturing residues, cleaning residues, impurities, etc.)
10. Biological Risk Assessment (BRA)
Toxi Plan prepares the complete biological evaluation report of your medical device and concludes on its safety in accordance with the ISO 10993 suite, for integration into your technical documentation.
1- We carry out the classification of DM according to regulation (EU) 2017/745 and standard ISO 10993-1.
2- We define the biological assessment strategy best suited to your project.
3- Study of the characteristics of materials and packaging.
4- Study of extractables and leachables with the participation of our network of partner laboratories.
5- Study of the sterilization process (optional, is carried out if needed).
6- Writing a literature review on similar devices on the market and establishing an equivalence (of materials, exposure, etc.).
7- Drafting toxicological profiles of materials, assessing exposure and calculating safety margins.
8- Toxicological risk assessment of manufacturing and cleaning processes.
9- Study of extractables and releasables: calculation of AETs in accordance with ISO 10993-18.
10- Preparation of toxicological profiles of relevant extractables/leachables, exposure assessment and calculation of safety margins in accordance with ISO 10993-17
11- Planning and management of biocompatibility studies: we support you with our network of European partner laboratories to complete the missing data.
12- Toxicological and biological risk assessment report. Analysis of existing toxicological data to leverage existing data, selection of data required to ensure the biological safety of your medical devices.
For Manufacturers
Toxi Plan help you to introduce a safe medical device to the global market.
For Patients
So that patient can use them with the upmost safety in regard of their health.
For Doctors
So that they feel comfortable using high-end equipment that offers maximum safety.