We help in turning your medical device idea into a real product with mechanical design, FEA and prototyping support

We are masters of design control and risk management process both in remediation as in new product development

We can create your QMS from zero or update existing one to comply to ISO 13485, ISO 9011, ISO 27000, MDSAP

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.

At TSQ&E, our expert consultants are known to provide impeccable services to various clients looking for FDA regulatory submissions.

The EU In Vitro Diagnostic Regulation (IVDR) imposes stringent requirements for technical documentation, clinical evidence, post-market surveillance, and supply chain transparency.

We perform process validation such as IQ/OQ/PQ and GAMP5 validation for manufacturing process of medical device and pharma products

We have internal Clinical Experts, team and process to perform Clinical Evaluations 360° from CEP, to Literature Search and CER

We provide full expertise for MDR, IVDR and allow swift market access with EUAR, CHAR and UK Rep Services

We can help getting your medical device registered worldwide from Americas, to middle east, far east, MENA

We have developed the most advanced, competitive, MDR and FDA compliant solution to manage and share your eIFU

We can manage your design verification activities and testing for mechanical, packaging, biocompatibility, electrical safety, cybersecurity, usability purposes

TS Quality and Engineering, with offices and representatives in the Switzerland, Italy and the UK, provides strategic compliance solutions to navigate post-Brexit regulatory requirements for medical devices and IVDs.