Casus Consulting
Casus Consulting is a specialized consultancy assisting companies with regulatory compliance for medical devices and IVDs in Europe, the UK, and Switzerland. They offer expertise in EU Authorized Representation, UK Responsible Person services, and Swiss Authorized Representation.
Casus Consulting provides expert guidance for navigating the complex regulatory landscapes of Europe, the United Kingdom, and Switzerland for medical devices and in vitro diagnostic devices (IVDs). Their services include acting as an EU Authorized Representative, fulfilling the role of a UK Responsible Person for MHRA device registration and UKCA marking, and serving as a Swiss Authorized Representative for Swissmedic device registration. With a focus on market access, Casus Consulting helps manufacturers understand and comply with regulations such as the MDR CE Marking and IVDR CE Marking in the EU, and the specific requirements for the UK and Switzerland. They are adept at managing the 'Steps to Market' in these key regions. Recent updates highlight their knowledge of the Swiss regulatory framework, including the alignment of Swissmedic's Manufacturer Incident Report (MIR) form with EU standards, demonstrating their commitment to keeping clients informed of evolving requirements.
About
**Who they are**
Casus Consulting is a specialized consultancy that assists companies with regulatory compliance for medical devices and IVDs in Europe, the UK, and Switzerland. They offer expertise in EU Authorized Representation, UK Responsible Person services, and Swiss Authorized Representation.
**Expertise & scope**
* Swiss Authorized Representation (CH-REP) services, including contract setup and registration with 'swissdamed' within 2-4 weeks.
* Guidance on obtaining CE marking for medical devices and IVDs as a prerequisite for the Swiss market.
* Support for manufacturers navigating the post-Mutual Recognition Agreement landscape between Switzerland and the EU.
* Verification of device compliance with Swiss medical device ordinances.
**Reputation / proof points**
* Trusted by over 250 medical device & IVD manufacturers across 20 countries.
Casus Consulting is a specialized consultancy that assists companies with regulatory compliance for medical devices and IVDs in Europe, the UK, and Switzerland. They offer expertise in EU Authorized Representation, UK Responsible Person services, and Swiss Authorized Representation.
**Expertise & scope**
* Swiss Authorized Representation (CH-REP) services, including contract setup and registration with 'swissdamed' within 2-4 weeks.
* Guidance on obtaining CE marking for medical devices and IVDs as a prerequisite for the Swiss market.
* Support for manufacturers navigating the post-Mutual Recognition Agreement landscape between Switzerland and the EU.
* Verification of device compliance with Swiss medical device ordinances.
**Reputation / proof points**
* Trusted by over 250 medical device & IVD manufacturers across 20 countries.
Additional information
Casus Consulting emphasizes a fast and responsive approach to Swiss Authorized Representative services, aiming for full setup and registration within 2-4 weeks. They provide direct access to a dedicated regulatory contact, avoiding generic inboxes. Their pricing model is transparent and flat-fee. Manufacturers are advised that CE marking is a mandatory requirement before products can be sold in Switzerland, and technical documentation based on MDR/IVDR requirements may need review by a Notified Body. While Swiss Authorized Representatives are not obligated to notify Class I devices for third-country manufacturers, they must verify compliance with the Swiss medical device ordinance.
Key Highlights
-
Offers full Swiss AR setup and 'swissdamed' registration in 2-4 weeks.
Source
“✓ Full Swiss AR setup from contract to ‘swissdamed’ registration in just 2-4 weeks”
-
Trusted by over 250 medical device & IVD manufacturers globally.
Source
“Trusted by 250+ medical device & IVD manufacturers across 20 countries”
-
Provides fast, responsive support from experienced regulatory professionals.
Source
“✓ Fast, responsive support from experienced regulatory professionals”
Certifications & Trust Signals
-
Specializes in regulatory compliance for medical devices and IVDs.
Source
“Casus Consulting is a specialized consultancy assisting companies with regulatory compliance for medical devices and IVDs”
Buyer Snapshot
Best for
- Manufacturers seeking Swiss Authorized Representation.
- Companies needing assistance with EU and UK regulatory compliance.
How engagement typically works
- Direct access to dedicated regulatory contacts.
- Transparent, flat-fee pricing.
Typical deliverables
- Swiss AR setup and 'swissdamed' registration.
- Regulatory compliance guidance for medical devices and IVDs.
- Support for CE marking and UKCA marking processes.
Good to know
- Best when manufacturers have already obtained or are pursuing CE marking for their devices.
Pricing
Model:
Custom pricing
HQ:
Boston, Switzerland
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
Device Classes Supported:
IVD
Vigilance Contact Support:
Yes
Can Be Named On Label:
Yes
Swiss Local Contact:
Yes
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
Full Swiss AR setup from contract to ‘swissdamed’ registration in 2-4 weeks. Requires CE marking and technical documentation based on MDR/IVDR. Swissmedic registration is a separate step.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
All classes (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
Labeling Support
Implied, as AR is responsible for verification of compliance.
Swiss Local Contact
Yes
Vigilance Contact Support
Implied as part of AR responsibilities.
Can Be Named On Label
Not explicitly stated, but typical for an AR.
