TS Quality & Engineering
TS Quality & Engineering is an ISO 13485-certified consultancy supporting medical device, IVD and pharmaceutical companies from initial concept to global market introduction.
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About
**Who they are**
TS Quality is a Swiss Authorized Representative provider. They focus on ensuring compliance for medical devices within Switzerland.
**Expertise & scope**
* Serves as the Swiss Authorized Representative for medical device manufacturers.
* Facilitates market access for devices in Switzerland.
* Ensures adherence to Swiss regulatory requirements for medical devices.
**Reputation / proof points**
* Coverage: CH
TS Quality is a Swiss Authorized Representative provider. They focus on ensuring compliance for medical devices within Switzerland.
**Expertise & scope**
* Serves as the Swiss Authorized Representative for medical device manufacturers.
* Facilitates market access for devices in Switzerland.
* Ensures adherence to Swiss regulatory requirements for medical devices.
**Reputation / proof points**
* Coverage: CH
Additional information
TS Quality acts as the crucial link between medical device manufacturers and the Swiss regulatory landscape. They are responsible for ensuring that devices placed on the Swiss market meet all applicable national requirements. This includes maintaining necessary documentation and acting as a point of contact for Swiss authorities. Their services are essential for manufacturers seeking to distribute their products within Switzerland, ensuring smooth market entry and ongoing compliance.
Key Highlights
-
Provides Swiss Authorized Representative services for the CH market.
Source
“Coverage: CH”
Certifications & Trust Signals
-
Company is formed by specialized professionals.
Source
“We are a company formed by specialized professionals.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking Swiss market access
- Companies needing a local Swiss Authorized Representative
How engagement typically works
- Local representation and compliance management
- Liaison with Swiss regulatory authorities
Typical deliverables
- Designation as Swiss Authorized Representative
- Compliance documentation support
- Local contact point for regulatory matters
Good to know
- Best when the primary goal is to place medical devices on the Swiss market.
Facts
More about our services
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
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
HQ:
Zug, Switzerland
Languages:
English, German, French, Italian
Timezones:
Europe/Zurich
Claim status:
Claimed
Services & Capabilities
Find CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH, EU, UK, US, AU, JP, BR, Global
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
6-25
Response SLA:
48 hours
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
IVD, Class I, Class III, Class IIa, Class IIb
Swiss Local Contact:
Yes
Labeling Support:
No
Swiss Entity Canton Or Region:
CH
Can Be Named On Label:
No
Vigilance Contact Support:
No
eu_ar
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
Class I, Class IIb, Class Is/Im/Ir, Class III, Class IIa, IVD
Post Market Support:
Yes
Labeling Review:
Yes
EU Entity Country:
italy
Can Be Named On Label:
No
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
eifu_platform
Jurisdictions:
EU, UK, CH, US, AU, JP, BR, Global
Response SLA:
12 hours
Pricing model:
Custom pricing
Multilingual Support:
Yes
Qr Or UDI Linking:
Yes
Validation Pack:
Yes
Compliance Certifications:
iso 27000, GDPR, ISO 13485
eudamed_reg_support
Supports Actor Registration:
Yes
Supports UDI:
Yes
Supports Data Load:
Yes
Modules Supported:
Actor/SRN, Clinical investigations, UDI/Devices, Vigilance, Certificates, Not sure
Supports Training Enablement:
Yes
importer_distributor_compliance
Training Available:
No
Template Pack Available:
No
Deliverables:
SOPs, Audit support, Templates pack, Ongoing retainer, Training
fda_qmsr_transition_inspection_readiness
Service Types:
QMSR/ISO 13485 Gap Assessment, CAPA & Nonconformance Remediation, Mock FDA Inspection, Supplier Controls / Quality Agreements, Training & Competency Programs, SOP / Documentation Remediation, Design Controls / DHF Modernization, Internal Audit Program Upgrade, 483 Response & Remediation Support
Inspection Experience:
Former FDA investigator on team, MDSAP experience, Supports mock inspections regularly, ISO 13485 lead auditor capability
eudamed_onboarding_support
Modules Supported:
Actor/SRN, Market Surveillance, UDI/Devices, Certificates
Submission Approach:
Portal, Bulk Submissions, M2M Integration
Managed Service Available:
No
Integration Support:
Access point onboarding, Labeling mapping, ERP/PLM mapping
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