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.

Posts (6)

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.

TS Quality & Engineering August 6, 2021
Product Highlight

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.

TS Quality & Engineering July 20, 2021
Service Highlight

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.

TS Quality & Engineering July 20, 2021
Service Highlight

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.

TS Quality & Engineering July 20, 2021
Service Highlight

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.

TS Quality & Engineering April 11, 2019
Service Highlight

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.

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.