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, endotracheal tubes, dressings, dental gels, nasal/ear sprays, pain relief gels, sanitary tampons…
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.