Patient safety is at the center of our concerns.
Speed up your time-to-market is essential to fulfill this goal.
Whether you are a legal manufacturer of medical devices, a subcontractor or a supplier,
CEHTRA supports you throughout the life cycle of your medical device, from design to post-marketing follow-up, including CE marking.
We provide our independence and expertise in biological risk assessment to demonstrate the biological safety of your device.
The transversality of our expertise in sectors such as pharmaceuticals, biocides, cosmetics and chemicals (REACH) enables us to provide you with the most detailed support.
Our expertise includes the Devices without an intended purpose, the borderline products
To guarantee the biocompatibility of materials and substances of medical device
To ensure compliance with regulatory requirements throughout the life cycle of medical devices
To guarantee regulatory compliance based on regulatory requirements and EN ISO 13485
To ensure that the products that are part of your processes comply with REACh regulations
Assessment of the biological risk associated with a product or material
Evaluation and testing within a risk management process standard (EN ISO 10993-1:2020) and the MD Regulation
Review of predicates, materials, processes and components to inform manufacturer of known and potential biological and toxicological hazards and regulatory implications.
Establishment of allowable limits for leachable substances (EN ISO 10993-17)
Chemical characterization of medical device materials within a risk management process (EN ISO 10993-18)
Recommendation of control measures to reduce risk, whether through testing or by establishing the safety of materials and processes.
Regulatory Affairs Support
General regulatory support:
Need an answer? A problem to assess? Need advice on how to respond to the Notified Body on a biosafety issue?
Crisis management support:
To help to prepare or develop an effective response before or after receiving an inspection notification from the competent authority, or a warning letter.
To help to prepare an effective response to Nonconformity from notified bodies
Modification evaluation support:
Evaluation of the impact of a modification on the biocompatibility of the material/medical device
Mentoring to assist the manufacturer in the characterization of the modification
Based on Quality management system standard (ISO 13485) & MDR
To assist on set up a QMS, we make ourselves available to challenge your system.
PRRC (Person responsible for regulatory compliance)
Possible to externalize this function for specific SMEs manufacturers
Registration of chemical substances to meet the requirements of the REACh regulation
Authorization: prohibited substances for which an authorization of use can be set up
Monitoring of hazardous substances (SVHC, restricted substances, endocrine disruptors,...)
Your tailormade Safety Data Sheets (SDS)
Global and transversal approach
Data and bibliographic analysis for Biological Safety
High level of expertise in toxicology and medical device kept up to date (ISO/EN)
Training: Regulatory Affairs, Biological Safety, standardization
Independence from labs