TS Quality
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About
**Who they are**
TS Quality & Engineering is a company comprised of specialized professionals focused on providing services to companies in the mechanical and medical industries. They leverage a network of consultants and suppliers to support new product development from initial design through validation, verification, regulatory pathways, and production.
**Expertise & scope**
* Design & Engineering
* Design Control Process
* Medical Device Development
* Special support for Start-ups
* Mechanical Design
* Pre-series and Prototype
* Usability & HFE
* Finite Element Analysis
* Composite and Biopolymers
* Reverse Engineering – Laser Scanning
* 3D Tomography Analysis
* Rapid Prototyping
* Gap Analysis (MDR)
* MDR Transition
* PRRC
* EU AR
* Swiss AR
* UK Responsible Person
* Design Control/DHF
* Risk Management
* Clinical Evaluation
* E-IFU Portal
* Biological/toxicological Evaluation
* Process Validation / IQ / OQ / PQQSM
* Product Development
**Reputation / proof points**
* Supports companies operating in the mechanical and medical industry.
* Facilitates product development from design input to validation and verification activities, regulatory path, first series release, and production phase.
* Actively seeks to expand its network of freelance and SME consultants in the Medical Device and Pharma fields.
TS Quality & Engineering is a company comprised of specialized professionals focused on providing services to companies in the mechanical and medical industries. They leverage a network of consultants and suppliers to support new product development from initial design through validation, verification, regulatory pathways, and production.
**Expertise & scope**
* Design & Engineering
* Design Control Process
* Medical Device Development
* Special support for Start-ups
* Mechanical Design
* Pre-series and Prototype
* Usability & HFE
* Finite Element Analysis
* Composite and Biopolymers
* Reverse Engineering – Laser Scanning
* 3D Tomography Analysis
* Rapid Prototyping
* Gap Analysis (MDR)
* MDR Transition
* PRRC
* EU AR
* Swiss AR
* UK Responsible Person
* Design Control/DHF
* Risk Management
* Clinical Evaluation
* E-IFU Portal
* Biological/toxicological Evaluation
* Process Validation / IQ / OQ / PQQSM
* Product Development
**Reputation / proof points**
* Supports companies operating in the mechanical and medical industry.
* Facilitates product development from design input to validation and verification activities, regulatory path, first series release, and production phase.
* Actively seeks to expand its network of freelance and SME consultants in the Medical Device and Pharma fields.
Additional information
TS Quality & Engineering offers a comprehensive approach to product development, particularly for the medical and mechanical sectors. They emphasize their ability to guide clients through the entire lifecycle of a new product, from initial concept and design through to validation, verification, and the complexities of regulatory compliance. Their services are structured to support start-ups and established companies alike, providing specialized assistance in areas such as design control, risk management, and clinical evaluation. The company also actively cultivates a network of specialized consultants, indicating a flexible and scalable approach to project needs.
Key Highlights
-
Provides specialized support for start-ups in product development.
Source
“Special support for Start-ups”
-
Offers services including MDR Gap Analysis, MDR Transition, EU AR, and Swiss AR.
Source
“Subject Area Free MDR Gap AnalysisMDR TransitionPRRCEUARSwiss ARUK Resp Person”
-
Expertise covers a wide range of medical device development areas, from design control to process validation.
Source
“Design Control/DHFHFE/UsabilityRisk ManagementClinical EvaluationE-IFU PortalBiological/toxicological Evaluationprocess Validation”
-
Engages with companies in both the mechanical and medical industries.
Source
“We provide services to companies operating in the mechanical and medical industry.”
Certifications & Trust Signals
-
Operates with a network of specialized consultants and suppliers.
Source
“With the aid of our network of consultants and suppliers we are able to follow the development of a new product”
Buyer Snapshot
Best for
- Medical device companies seeking end-to-end product development support
- Mechanical industry companies requiring design and engineering expertise
- Start-ups needing specialized guidance through regulatory pathways
How engagement typically works
- Collaborative project-based support
- Leveraging a network of specialized consultants
- Guidance through regulatory processes
Typical deliverables
- Product design and engineering
- Regulatory strategy and implementation (MDR, EU AR, Swiss AR, UK RP)
- Validation and verification documentation
- Prototyping and pre-series production support
Good to know
- Best when requiring specialized expertise in mechanical and medical device development.
HQ:
Lausanne, US
Languages:
English, German, French
Timezones:
Europe/Zurich
Status:
listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
6-25
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
Swiss Local Contact:
Yes
Labeling Support:
No
Can Be Named On Label:
No
Vigilance Contact Support:
No
Device Classes Supported:
IVD
Additional ch_rep Details
Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
Clients can book a free call to discuss needs or provide information in writing for a quote. A form is available to submit details and request information/quote.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Labeling Support
true
Swiss Local Contact
true
Vigilance Contact Support
true
Supports MDR
Yes
Supports IVDR
false
Can Be Named On Label
true
