TS Quality
TeamSpeak Systems, Inc.
TeamSpeak offers crystal-clear, lag-free voice communication with military-grade security and unparalleled reliability. It provides users with complete control over their communication experience, focusing on privacy and advanced features.
TeamSpeak is a leading provider of voice communication solutions, renowned for its crystal-clear sound quality, lag-free performance, and military-grade security. Designed for teams and communities, it offers unparalleled reliability and uptime, ensuring seamless communication across platforms. A key differentiator for TeamSpeak is its commitment to user control and privacy; unlike other solutions, it does not rely on centralized servers, does not harvest user data for sale, and empowers users to dictate how their communication environment functions. The platform boasts advanced features such as automatic microphone volume adjustment, background noise reduction, and echo cancellation for an optimal audio experience. Users benefit from secure global messaging, simple cross-device setup, and access to over 100 add-ons, skins, and voice packs. TeamSpeak is dedicated to providing a secure, private, and highly customizable communication environment, making it the preferred choice for gamers, businesses, and organizations seeking robust and reliable voice services.
About
**Who they are**
TS Quality is a company formed by specialized professionals providing services to companies operating in the mechanical and medical industries. They leverage a network of consultants and suppliers to support product development.
**Expertise & scope**
* Full product development lifecycle support, from design input to validation and verification.
* Regulatory path guidance.
* Support for first series release and production phases.
* Specialized support for start-ups.
* Design & Engineering services.
* Design Control Process.
* Medical Device Development.
* Mechanical Design.
* Pre-series and Prototype development.
* Usability & HFE (Human Factors Engineering).
* Finite Element Analysis.
* Composite and Biopolymers expertise.
* Reverse Engineering – Laser Scanning.
* 3D Tomography Analysis.
* Rapid Prototyping.
* Gap Analysis for MDR (Medical Device Regulation).
* MDR Transition support.
* PRRC (Person Responsible for Regulatory Compliance) services.
* EU Authorized Representative (EU AR) services.
* Swiss AR (Authorized Representative) services.
* UK Responsible Person services.
* Design Control/DHF (Design History File) support.
* Risk Management.
* Clinical Evaluation.
* E-IFU (Electronic Instructions for Use) Portal.
* Biological/toxicological Evaluation.
* Process Validation / IQ / OQ / PQQ.
* SM (Supplier Management).
* Product Development.
**Reputation / proof points**
* Offers opportunities for freelance and SME consultants in the Medical Device and Pharma fields to expand their business by joining their network.
TS Quality is a company formed by specialized professionals providing services to companies operating in the mechanical and medical industries. They leverage a network of consultants and suppliers to support product development.
**Expertise & scope**
* Full product development lifecycle support, from design input to validation and verification.
* Regulatory path guidance.
* Support for first series release and production phases.
* Specialized support for start-ups.
* Design & Engineering services.
* Design Control Process.
* Medical Device Development.
* Mechanical Design.
* Pre-series and Prototype development.
* Usability & HFE (Human Factors Engineering).
* Finite Element Analysis.
* Composite and Biopolymers expertise.
* Reverse Engineering – Laser Scanning.
* 3D Tomography Analysis.
* Rapid Prototyping.
* Gap Analysis for MDR (Medical Device Regulation).
* MDR Transition support.
* PRRC (Person Responsible for Regulatory Compliance) services.
* EU Authorized Representative (EU AR) services.
* Swiss AR (Authorized Representative) services.
* UK Responsible Person services.
* Design Control/DHF (Design History File) support.
* Risk Management.
* Clinical Evaluation.
* E-IFU (Electronic Instructions for Use) Portal.
* Biological/toxicological Evaluation.
* Process Validation / IQ / OQ / PQQ.
* SM (Supplier Management).
* Product Development.
**Reputation / proof points**
* Offers opportunities for freelance and SME consultants in the Medical Device and Pharma fields to expand their business by joining their network.
Additional information
TS Quality facilitates engagement through various channels, including booking a free call to discuss specific needs or submitting information in writing. They offer a structured approach to product development and regulatory compliance, catering to both established companies and start-ups. Their services encompass a wide range of technical and regulatory aspects crucial for bringing medical devices to market. Buyers can expect support from initial design concepts through to production and post-market activities. The company also actively seeks to expand its network by engaging with freelance consultants in the medical device and pharmaceutical sectors.
Key Highlights
-
Provides Swiss AR services.
Source
“Subject Area Free MDR Gap AnalysisMDR TransitionPRRCEUARSwiss ARUK Resp Person”
-
Offers EU Authorized Representative (EU AR) services.
Source
“Subject Area Free MDR Gap AnalysisMDR TransitionPRRCEUARSwiss ARUK Resp Person”
-
Provides UK Responsible Person services.
Source
“Subject Area Free MDR Gap AnalysisMDR TransitionPRRCEUARSwiss ARUK Resp Person”
-
Supports companies in the mechanical and medical industry.
Source
“We provide services to companies operating in the mechanical and medical industry.”
-
Assists with Medical Device Development and Design Control Processes.
Source
“Design Control Process Medical Device Development”
Certifications & Trust Signals
-
Company is formed by specialized professionals.
Source
“We are a company formed by specialized professionals.”
Buyer Snapshot
Best for
- Medical device companies seeking end-to-end product development support.
- Start-ups requiring specialized guidance through regulatory pathways.
- Companies needing assistance with MDR/IVDR compliance and Swiss/EU/UK representation.
How engagement typically works
- Consultative approach via free calls.
- Written communication for project details.
- Network-based collaboration for specialized expertise.
Typical deliverables
- Design History Files (DHF).
- Risk Management Files.
- Clinical Evaluation Reports.
- Regulatory strategy and submissions.
- Swiss, EU, and UK Authorized Representative services.
Good to know
- Best when requiring comprehensive support across design, development, and regulatory compliance for medical devices.
HQ:
Lausanne, US
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim 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
Information can be provided via written submission or a free call to discuss needs. A quote is provided after initial information is submitted.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Labeling Support
true
Swiss Local Contact
Yes
Vigilance Contact Support
true
Supports MDR
Yes
Supports IVDR
No
Can Be Named On Label
true
⚡ Instant booking available
Appoint a Swiss Authorized Representative (CH-REP) for Medical Devices
Compare TS Quality and other vetted providers — instant pricing, no RFQ needed.
