Get your product approved
Your Permeation Report In A Few Weeks Fully Compliant Without Stress
Execute a comprehensive permeation study for your Substance-Based Medical Devices. The study design is fully compliant with Notified Body standards, ensuring a seamless MDR approval. So you can have the freedom to focus on what really matters to you.
Trusted By
Your Path To Effortless Approval
A technical file with non-compliant permeation data will inevitably result in lengthy resubmissions and delays.
The main problems are:
Poor communication
Prevents scientific knowledge from being applied to regulatory requirements.
Flawed study design
The scientific protocol doesn't represent the medical device’s real-world use.
Non-compliant data
Unfit permeation data cause the rejection of your technical file by the Notified Body.
Your Permeation Studies
with
Technology Scientific
Compliant with MDR 2017/745
The protocol is drafted in accordance with the guidelines OECD 428 and validated as per ICH Q2(R1).
Dedicated
Communication
Unlimited consultation time to build a compliant study, collaborating with you via phone, remote meetings, and email.
Always
Updated
You will always be informed of your study's progress through every stage with automated emails.
Quick
Delivery
From your first and free consultation to the study report in your inbox in just a few weeks.
How Does It Work
Book A Free Consultancy
30 minutes completely free, we will asses what is the best approach for your product to get the data it needs.
Monitor The Testing
Once the study starts, you will receive in your in-box an automated email informing you at what stage is your permeation study:
- Material receiving
- Start experimental activities
- End experimental activities
- Start reporting
- Closing and report forwarding.
Receive The Repeort
In few weeks you will receive a full report ready to be included in your technical file.
Ready To Stop The Uncertainty?
Compliant with MDR 2017/745
Dedicated Communication
Always Updated
Quick Delivery
