TS Quality

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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

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.
HQ: Lausanne, US
Languages: English, German, French
Timezones: Europe/Zurich
Claim status: Listed

Services & Capabilities

Find 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
Swiss Entity Canton Or Region: CH

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
The website indicates a process involving filling out contact forms to receive required information and a quote, and offers the option to book a free call to discuss needs.
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
true
Supports IVDR
No
Can Be Named On Label
true
Swiss Entity Canton Or Region
CH
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