SMQS
Arnold Bott AG
SMQS acts as the Swiss Authorized Representative (CH-REP) for international medical device manufacturers, ensuring compliance with Swiss market access regulations and facilitating product registration and market entry.
Swiss Medical Quality Services (SMQS) serves as the Swiss Authorized Representative (CH-REP), assisting international manufacturers in obtaining market access for their medical devices (MDR/IVDR) within Switzerland. They manage formal and safety-related responsibilities for bringing products into the Swiss market, ensuring adherence to all legal requirements. SMQS offers comprehensive services including product registration support, compliance with legal provisions, and cooperation with authorities on preventive or corrective actions. Their expertise is built on years of experience with established companies in the Swiss medical and dental markets, providing a streamlined path for global manufacturers to enter and succeed in Switzerland.
About
**Who they are**
SMQS acts as the Swiss Authorized Representative (CH-REP) for international medical device manufacturers. They focus on ensuring compliance with Swiss market access regulations.
**Expertise & scope**
* Facilitating product registration and market entry into Switzerland.
* Ensuring compliance with Swiss market access regulations for medical devices.
* Providing the necessary CH-REP services for international manufacturers.
**Reputation / proof points**
* Coverage: CH
SMQS acts as the Swiss Authorized Representative (CH-REP) for international medical device manufacturers. They focus on ensuring compliance with Swiss market access regulations.
**Expertise & scope**
* Facilitating product registration and market entry into Switzerland.
* Ensuring compliance with Swiss market access regulations for medical devices.
* Providing the necessary CH-REP services for international manufacturers.
**Reputation / proof points**
* Coverage: CH
Additional information
Engaging SMQS as your Swiss Authorized Representative involves understanding their role in navigating Swiss regulations for medical device market access. They facilitate product registration and entry by ensuring compliance with local requirements. Buyers should consider the specific documentation and timelines required for the CH-REP appointment process, which SMQS will guide them through. Their services are crucial for manufacturers looking to place their devices on the Swiss market.
Key Highlights
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Acts as the Swiss Authorized Representative (CH-REP) for international medical device manufacturers.
Source
“SMQS acts as the Swiss Authorized Representative (CH-REP) for international medical device manufacturers”
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Ensures compliance with Swiss market access regulations.
Source
“ensuring compliance with Swiss market access regulations”
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Facilitates product registration and market entry into Switzerland.
Source
“facilitating product registration and market entry.”
Certifications & Trust Signals
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Provides coverage for Switzerland (CH).
Source
“Coverage: CH”
Buyer Snapshot
Best for
- International medical device manufacturers seeking Swiss market access
- Companies needing a dedicated Swiss Authorized Representative (CH-REP)
How engagement typically works
- Direct engagement for regulatory compliance
- Facilitation of product registration and market entry
Typical deliverables
- CH-REP services
- Ensuring compliance with Swiss regulations
- Support for product registration and market entry
Good to know
- Best when the manufacturer is based outside of Switzerland and requires a local representative.
HQ:
Glattbrugg, CH
Languages:
English, German, French, Italian
Timezones:
CET
Status:
listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical Devices, Pharmaceuticals, Biotech, IVD
Onboarding time:
3–14 days
Pricing model:
Custom pricing
Swiss Local Contact:
Yes
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Additional ch_rep Details
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
