TS Quality & Engineering is a ISO 13485 certified company. We offer Medical Device Consulting Services and solutions aimed at facilitating, speeding up and support design, validation, regulatory and quality control process. We can follow the design and development of a new product at all stages.
Hall 2 / F 2187
Hall 2 / F 2187
We provide an innovative tool to manage your IFU digitally and in full compliance with MDR regulation.
This will result in huge savings and burden reduction for your company.
Design controls in the early development phase are essential for the development of a high-performance medical device. Design control is part of effective risk management to bring a safe product to market on time and within budget.
With our team of SMEs and Regulatory experts we provide support to companies in different fields and with different kind of products going through the changes introduced by new MDR.
MedQuality is a project to improve the quality of medical devices and healthcare services. With the implementation of blockchain technology in the supply chain, complaint tracking, training, and maintenance, safety and quality can be increased.
The website eu-mdr.eu is intended to help companies from different sectors and with different products to reach the safe haven of MDR conformity in an efficient way.
TS Quality & Engineering can follow the design and development of a new product at all stages, we have huge experience in medical device industry and international regulated market.
TS Quality & Engineering offers Medical Device Consulting Services aimed at facilitating, speeding up and support:
• Design & Development• Process Validation • Regulatory Support• Quality System and Compliance
We Are a Team of Engineers and Subject Matter Experts with a long experience in the Medical Device field, this allow us to quickly find the right approach for the projects, optimizing development basing on regulatory field, applicable international standards and previous experience with the biggest market leader companies.
TS Quality & Engineering is able to follow and support in all needed procedure to take your product into the market, from building up technical file and design control documentation to create and improve company Quality System in order to control processes and assure compliance.
We always try to design guidelines, procedures, quality system and documentation in the best way to make easy the update of the information and provide the best match with existing documents.
We develop our projects with the aid of our network of certified and reliable suppliers and partners.
This allow us to provide always the best service and the needed expertise to guarantee the high quality level results we expect.
Legal OfficeVia Riva del garda 747838 Riccione
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