About Cetry

Cetry Activities

Cetry helps medical device manufacturers and their suppliers by means of problem solving, process modelling, characterization of product properties, device and materials qualification, process and manufacturing validation, related regulatory issues, quality assurance, and design and build of specialized equipment. The emphasis is on assistance related to invasive blood-contacting medical devices, materials (e.g. excipients) and coatings. We generally (but not exclusively) work for (medical) material developers, medical device developers/manufacturers and companies that need assistance with quality assurance. We work both on-site as well as off-site, in order to solve problems, set up quality management systems, introduce improved manufacturing techniques, define quality- and in-process control, generate data for process modelling and characterization, etc.
Cetry is an independent organization, not legally or effectively linked to other companies.


Key words: Problem solving - modelling of processes and product performance - characterization - risk analysis - interim quality management - hands-on mentality - medical coatings - heparin - hydrogel - plasma-treatment - diagnostic and guiding catheters - excipients - PTA/PTCA balloon catheters - infusion tubing - pacer leads - stents - definition of quality- and in-process control - process validation - device qualification - MDD - CE-marking - essential requirements - ISO 13485 - European Pharmacopoeia - U.S. Pharmacopeia - demarcation between medical and medicinal devices - adhesive bonding - UV curing - artificial and real-time aging - handling and storage protocols and testing - calibration - risk analysis.


Orientation:
Examples of Cetry activities can be found under CASES or through the links below:

Background

Cetry was founded in 1998 and is located in the beautiful province of Groningen, The Netherlands (photos below). Founder Jan Bos had noticed that - with many players in the field of medical device manufacturing - there existed only few organizations that were able to provide highly specialized independent assistance. With Cetry it became possible to bridge the gap between material developers and medical device manufacturers. This gap is mainly caused by the various quality and regulatory demands as well as the required level of familiarity with clinical application of the devices. That is why Cetry's core business includes QA and RA, next to problem solving and development assistance. Cetry has also been active in the background, helping set up new business ventures in the field of medical device and materials development/manufacturing. Experience is based on a long track record from working for various medical device companies. Specialization is found in coating development (heparin, hydrogel, silicone, coating deposition, general surface treatments), surface bonding, development and manufacture of diagnostic catheters (radiology, cardiology), excipient development and manufacture, CE-registration, and ISO13485-compliant quality management.

Contact

For information about how we might be of service to you, please write to the following e-mail address:



Please also use this address for inquiries related to business opportunities or product acquirement.