TS Quality & Engineering SRL

Founded in 2012, TS Quality & Engineering is an ISO 13485-certified consultancy supporting medical device, IVD and pharmaceutical companies from initial concept to global market introduction. With a multidisciplinary team and an international presence in Italy, Switzerland, the UK and China, we provide end-to-end support in Design Control and DHF, Risk Management, Human Factors, Biocompatibility and Toxicology, Clinical Evaluation and Studies, Quality Management Systems, Process Validation, MDR/IVDR and FDA compliance, international registrations, and EU-REP, CH-REP and UK Responsible Person services.

Our experience covers Class I–III medical devices, implantables, combination products, substance-based devices, electromedical equipment, IVDs, medical software and SaMD. We support both new product development and complex remediation programmes through flexible engagement models tailored to each client’s needs.

• Regulatory strategy and product classification
• Design Control and Design History File management
• DHF and technical documentation remediation
• Risk Management according to ISO 14971
• Design, Process and Usability FMEA
• Human Factors and Usability Engineering
• Biological Evaluation and Biocompatibility
• Toxicological Risk Assessment
• Clinical Evaluation and Clinical Investigation support
• CRO and clinical study management
• Verification and Validation
• Test Method Validation and Measurement System Analysis
• Process Validation
• Packaging and transportation validation
• Sterilization validation
• Design Transfer and Technology Transfer
• Quality Management Systems: ISO 13485, ISO 9001 and ISO 27001
• Computer System Validation and GAMP 5
• EU MDR and IVDR compliance
• FDA 510(k), De Novo and PMA support
• Drug-device combination-product compliance
• CE-marking and Notified Body submission support
• EU Authorized Representative services
• Swiss Authorized Representative services
• UK Responsible Person services
• EU and Swiss importer services
• PRRC outsourcing
• UDI, EUDAMED and Swissmedic/Swissdamed support
• Post-Market Surveillance and PMCF
• Vigilance and regulatory authority communication
• Worldwide product registrations
• MDSAP readiness and compliance
• Medical-device cybersecurity
• Software as a Medical Device and AI/ML regulatory support
• Internal and supplier audits
• Quality and regulatory training