TS Quality & Engineering

Short description

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.

Contact

Posts (9)

TS Quality & Engineering September 11, 2023
Service

510(k) Submission Support for Medical Devices

MDR is a great burden for all Medical Device Manufacturer. We suggest in many cases prioritizing a US FDA submission. We can assist in the whole process. Write to info@tsquality.ch for immediate assistance.

Swiss Medtech Expo 2023
TS Quality & Engineering July 14, 2023
Service

Get ready for MDR Transition now!

Trust the experts! We provide Certified Medical Device Consulting Services since 2010. We have developed a consolidated method for achieving MDR transition smoothly.

Swiss Medtech Expo 2023
TS Quality & Engineering July 13, 2023
Product

E-IFU Smart Solutions for Medical Device & Pharma

We provide an innovative tool to manage your IFU digitally and in full compliance with MDR/IVDR regulation for your medical device and in vitro diagnostic devices. This will result in huge savings and burden reduction for your company.

Swiss Medtech Expo 2023
TS Quality & Engineering September 9, 2021
Showcase

Start creating your MDR Transition Plan

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.

Swiss Medtech Expo 2021
TS Quality & Engineering August 6, 2021
Product

e-IFU/eManuals Solution - Smart Tools for Compliance

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.

Swiss Medtech Expo 2021
TS Quality & Engineering July 20, 2021
Service

MDR Compliance Support and EU Market Access - EU AR - PRRC

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.

Swiss Medtech Expo 2021
TS Quality & Engineering July 20, 2021
Service

Blockchain: Empowered Quality For Medical Device

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.

Swiss Medtech Expo 2021
TS Quality & Engineering July 20, 2021
Service

Design Control / DHF and Risk Management Consulting

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.

Swiss Medtech Expo 2021
TS Quality & Engineering April 11, 2019
Service

Medical Device Development

We provide support to our clients in getting trought all the product development stages. From ideation to final market introduction. We are ISO 13485 certified for Medical Device Design, Development and all related activities.

Swiss Medtech Expo 2019

Standards, Products, Services

  • S ISO 13485:2016
  • S 3D Scanning
  • S Further services development
  • S Product development
  • S Engineering services
  • S Design of parts for additive manufacturing
  • S Reverse engineering
  • S Simulation (FEM, process simulation, etc.)
  • S Industrial computed tomography
  • S Measuring, 3D scanning
  • S Technology development
  • S Application development
  • S Consulting
  • S Consulting additive manufacturing
  • S Certification
  • S Factory planning and realization
  • S Documentation
  • S Patents & IP
  • S Registration of medical devices
  • S Further services for manufacturers
  • S Contract research and development
  • S Further research and development
  • S Further services
  • S Computer system validation
  • S Training
  • S Services for clean room operators
  • S HR and recruiting services
  • S Additive manufacturing plastics
  • S Part testing
  • S Engineering of packaging solutions
  • S Clinical trials
  • S Consulting industry 4.0
  • S Consulting lean management
  • S Education
  • S Further education and training
  • S Rapid prototyping

About us

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.