Download our Free MDR Gap Analysis Tool Swiss AR / EUAR / UKREP - All in One - Ask an Offer Regulatory Support MDR - Technical File 510(k) / PMA Support DHF / Design Control Process Reach out for advice Biocompatibility ISO 10993 Strategy and BEP Toxicological Evaluations Biological Evaluation Report Reach out for advice Medical Device NPD Process New Product Development Start Developing a Medical Device with Expert Support FROM CONCEPT TO THE DEVICE Developing a succesfull Product Building your project team Request support Staffing Support

• What we do

  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.
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• Design & Dev.

  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.

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• QA/RA Support

  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. 

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• Medical Device Sensibility

  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.

  Smart Approach to Documentation

  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.

  Network of Certified Suppliers

  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.

• Documentation Expertise

Recent Works

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