Deflastrat S.L.
Medical device design
Engineering solutions for challenging problems
Production of medical devices
Founded in 2012
With the fundamental conviction of providing practical engineering solutions to the complex medical industry.
We have developed products and processes for different medical companies, who trust our high-quality work.
Our experience allows us to understand the high demands involved in developing medical devices, balancing them with the commercial needs for target price and profitability through effective project management.
Our services
Innovative solutions
Writing and management of intellectual property
With our own patents and those of third parties, Deflastrat has extensive experience in writing and managing intellectual property.
Review and compilation of technical files
Deflastrat has extensive experience in compiling and reviewing CE Technical Files.
Design and prototyping
At Deflastrat, we pride ourselves on offering practical engineering solutions to product or process problems.
Manufacturing
Tighter profit margins and globalisation have led companies to continuously strive for savings and cost improvements.
Validation
Our extensive experience in validation has been incorporated into all aspects of design and manufacturing.
Project management
To coordinate and monitor projects, Deflastrat employs effective project management techniques.
The company
The design of medical instruments and devices is not just about good design, but also a thorough understanding of risk management and regulatory pathways. Without this knowledge, product development can, at best, be delayed — and at worst, result in a faulty device.
We develop and manufacture Class I, IIa, and IIb medical devices as manufacturers and also for customers who produce the technical file and risk management reports required for registration.
We work with the latest guidelines and standards to ensure that developments can get the CE mark for the global market. Due to the complex nature and many disciplines involved, we can provide a Project Management service where all information can be focused and communicated effectively between all parties.
One of the challenges facing the medical industry today is providing cost-effective solutions, especially within a global market and strict reimbursement systems. This will become more challenging as healthcare budgets are cut and authorities want to see “value for money”.
Medical products are generally complex to manufacture. Together with rigorous quality controls and regulations, this can significantly reduce manufacturing efficiency.
Deflastrat has worked on all stages of process development, from establishing “proofs of concept” to implementing production lines.
Products and Projects
Aladin®
Production and commercial launch in France of the Aladin surgical drape.
Developed in collaboration with Sumisan.
Type I medical device.
Cbag
Development of a bag and its components for contained electrical morcellation.
Type IIa medical device.
TriHeat
Development of a disposable heating sheet to prevent hypothermia during surgical procedures.
Type IIb medical device.
Fulco
Development of an endoscope cover. Project in the prototyping phase with Medical Grade LSR.
Type IIa medical device.
Contact
DEFLASTRAT S.L.U.
Calle Aienas 3, local 23
Polígono 27
20014 Donostia-San Sebastián
España
943 26 57 36
Call us
943 26 57 36
Find us at
Calle Aienas 3, local 23, Poligono 27, 20014 Donostia-San Sebastián, España
Opening hours
Lun-Jue 09:00-13:00 / 14:00-17:00
Vie 09:00-14:00
Grants
