MedTech Compliance Switzerland
Elos Medtech
Elos Medtech is a leading CDMO specializing in Medtech solutions for dental, orthopedic, and advanced surgical industries. They offer end-to-end services from R&D to manufacturing and sterile packaging.
Elos Medtech is a trusted partner for the world's leading dental, orthopedic, and advanced surgical companies, offering comprehensive CDMO services. They excel in reimagining partnerships to enhance lives through best-in-class technology and pioneering sustainable Medtech solutions. Their expertise spans the entire product lifecycle, including Research and Development, Prototyping using advanced techniques like additive manufacturing and CNC machining, and "Design for Manufacturing" to optimize cost-effectiveness and quality. Elos Medtech also provides crucial services such as Sterilization Management, Registration and Technical Documentation, and Supply Chain Management. With a commitment to integrity, respect, and quality, Elos Medtech drives innovation and value across the supply chain. They are dedicated to meeting the evolving needs of the medical device industry, ensuring efficient, high-quality manufacturing while adhering to regulatory requirements. Their presence across three continents allows for unmatched local service and tailored support to meet unique market needs.
About
**Who they are**
MedTech Compliance Switzerland is a specialized consultancy focused on regulatory affairs for the medical technology sector. They provide expert guidance and services to ensure medical devices meet Swiss regulatory requirements.
**Expertise & scope**
* Navigating Swiss Medtech regulations
* Acting as a Swiss Authorized Representative
* Ensuring compliance for market access in Switzerland
**Reputation / proof points**
* Coverage: Switzerland (CH)
MedTech Compliance Switzerland is a specialized consultancy focused on regulatory affairs for the medical technology sector. They provide expert guidance and services to ensure medical devices meet Swiss regulatory requirements.
**Expertise & scope**
* Navigating Swiss Medtech regulations
* Acting as a Swiss Authorized Representative
* Ensuring compliance for market access in Switzerland
**Reputation / proof points**
* Coverage: Switzerland (CH)
Additional information
For medical device manufacturers seeking to enter or maintain their presence in the Swiss market, understanding the specific regulatory landscape is crucial. MedTech Compliance Switzerland offers tailored support to navigate these complexities. Their services are designed to facilitate market access by ensuring adherence to all relevant Swiss regulations, including acting as the designated Swiss Authorized Representative. This role is vital for foreign manufacturers to legally place their devices on the Swiss market. Engagement typically involves a thorough review of device documentation and regulatory strategy to align with Swiss requirements.
Key Highlights
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Specializes in Swiss regulatory compliance for medical technology.
Source
“MedTech Compliance Switzerland is a specialized consultancy focused on regulatory affairs for the medical technology sector.”
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Offers end-to-end services from R&D to market.
Source
“They offer end-to-end services from R&D to manufacturing and sterile packaging.”
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Covers the Swiss market (CH).
Source
“Coverage: CH”
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Supports multiple languages including English, German, and French.
Source
“Languages: English, German, French”
Certifications & Trust Signals
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Established entity providing CH-REP services.
Source
“MedTech Compliance Switzerland”
Buyer Snapshot
Best for
- Medical device manufacturers seeking Swiss market access
- Companies needing a Swiss Authorized Representative
How engagement typically works
- Consultative approach to regulatory compliance
- End-to-end support for Swiss market entry
Typical deliverables
- Swiss Authorized Representative services
- Regulatory compliance strategy for Switzerland
- Support with Swiss labeling and documentation
Good to know
- Best when requiring specific expertise in Swiss medical device regulations
HQ:
Skara, Sweden
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 2,000
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
Additional ch_rep Details
Supports MDR
true
Supports IVDR
true
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
true
Can Be Named On Label
Yes
