Cetry Services

Cetry offers a wide range of services related to the entire development route for medical devices and materials - from concept to release - including manufacturing, registration and quality assurance. We are specialized in providing support to medical device manufacturers and developers/manufacturers of medical materials. Click on ABOUT to contact us for specific inquiries about our services.

Development & Manufacturing Support The photograph shows a detail of a simple UV-curing test setup that was used for repair and optimization of an existing hydrogel coating for balloon catheters.	DEV & MANUF SUPPORT Cetry offers hands-on support for development of materials and devices. Think of problem solving of technical issues, risk assessment, definition and installation of in-process control (IPC), quality control (QC), design history profiling, capacity optimization, definition and deployment of handling and storage methods for products and materials, artificial and real-time aging programs and product performance programs. We are highly specialized in problem solving regarding surfaces and coatings of medical devices, behavior and purity of excipients as well as biocompatibility and adhesion issues regarding polymers.	more..
Characterization & Modelling Some characterization is done in-house. The photograph shows a detail of the static friction test controller.	CHAR & MODELLING Process and product performance characterization and modelling are part of our standard toolkit. Modelling of (sub-)processes for e.g. manufacturing, in-process control (IPC) and quality control (QC) as well as for product performance (including artificial aging modelling) help developers and manufacturers to (1) optimize the process and product performance, (2) reduce failure due to improved quality assurance, (3) open new ways for further development and innovation. Characterization tests are usually done on location with the available equipment and technicians or engineers (when desired), in order to fit the effort directly into the organization. Some characterization tests can be done in-house as well, such as heparin-leaching evaluation, precision static friction testing (wet and dry), UV-VIS measurements, pull testing, in-vitro coating-particle evaluation for clinical risk assessment, and surface tension measurements.	more..
QA & RA Support Quality Assurance consists of a few ever-recurring building blocks. Justification through validation (VAL) of procedures (PROC) and qualification (QUAL) of (design) specifications (SPEC) leads to manufacturing and product-design assurance. Reports in any form help build the knowledge base with which the company evolves.	QA & RA SUPPORT Quality Assurance (QA) and Requlatory Affairs (RA) are integral aspects of product development and commercialization. Cetry is specialized in offering assistance in the field of medical devices and medical materials, ranging from total interim QA-management to full-blown CE-marking of medical devices. Further activities are found in setting up and/or participating in risk management, hands-on guidance regarding calibration, quality control (QC), in-process control (IPC), and guiding of auditing (CE-audit, ISO-13485, customer audit). Do not hesitate to contact us if you want to have a completely new Quality Management System (QMS) set up by Cetry!	more..
Plasma Treatment The gas-discharge treatment is obtained by applying a high-voltage long-wave variable radio-frequency signal to the electrode inside the vacuum chamber. A detail of the in-house developed and built RF-generator is shown here	PLASMA TREATMENT Cetry is able to provide a set of simple gas-discharge treatments, aiming at improvement of surface-bonding of most polymers and coatings. Gasses include oxygen, air and water. Other gasses such as He and N2O can be applied on request. This service generally helps companies and laboratories that either have no plasma equipment or that do not want to run experiments on their own (manufacturing-) equipment. The Cetry equipment is able to perform in-situ temperature measurements. It runs on a long-wave variable frequency plasma generator (70 kHz - 300 kHz). Related services are: (1) bonding and surface wetting investigation of e.g. polymers, and (2) drying and melting of materials under vacuum (thus preventing of oxidation).	more..