Casus Consulting (UKRP)
Casus Consulting
Casus Consulting offers expert guidance for medical device market access in Europe, the UK, and Switzerland, specializing in regulatory compliance and registration.
Casus Consulting provides comprehensive support for navigating the complex regulatory landscapes of Europe, the UK, and Switzerland. They assist businesses with essential steps to market, including EU Authorized Representation, MDR and IVDR CE Marking, UK Responsible Person services, MHRA Device Registration, and UKCA Marking. Their expertise ensures smooth market entry and compliance for medical devices in these key regions.
About
**Who they are**
Casus Consulting (UKRP) provides expert guidance for medical device market access in Europe, the UK, and Switzerland, specializing in regulatory compliance and registration.
**Expertise & scope**
* Expert guidance for medical device market access in Europe, the UK, and Switzerland.
* Specialization in regulatory compliance and registration.
* Services include EU Authorized Representative, MDR CE Marking, IVDR CE Marking, Responsible Person, MHRA Device Registration, and UKCA Marking.
* Offers complete EU AR representation from initial mandate through ongoing compliance.
* Provides fast, responsive support from experienced regulatory professionals.
* Ensures direct access to a dedicated regulatory contact.
* Offers transparent, flat-fee pricing with no hidden costs.
**Reputation / proof points**
* Trusted by 250+ medical device & IVD manufacturers across 20 countries.
Casus Consulting (UKRP) provides expert guidance for medical device market access in Europe, the UK, and Switzerland, specializing in regulatory compliance and registration.
**Expertise & scope**
* Expert guidance for medical device market access in Europe, the UK, and Switzerland.
* Specialization in regulatory compliance and registration.
* Services include EU Authorized Representative, MDR CE Marking, IVDR CE Marking, Responsible Person, MHRA Device Registration, and UKCA Marking.
* Offers complete EU AR representation from initial mandate through ongoing compliance.
* Provides fast, responsive support from experienced regulatory professionals.
* Ensures direct access to a dedicated regulatory contact.
* Offers transparent, flat-fee pricing with no hidden costs.
**Reputation / proof points**
* Trusted by 250+ medical device & IVD manufacturers across 20 countries.
Additional information
Casus Consulting emphasizes a practical, business-minded approach to achieving regulatory compliance. They are equipped to assist with single elements of documentation or provide full support for market access processes. Their services are structured to offer clear steps, such as obtaining CE Marking, appointing an EU Authorized Representative, registering company and devices, and identifying EU Importers. For the UK market, they cover the role of the Responsible Person, MHRA Device Registration, and UKCA Marking. Pricing is available on a flat-fee basis, aiming for transparency.
Key Highlights
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Trusted by over 250 medical device and IVD manufacturers across 20 countries.
Source
“Trusted by 250+ medical device & IVD manufacturers across 20 countries”
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Offers complete EU Authorized Representative representation from initial mandate through ongoing compliance.
Source
“✓ Complete EU AR representation from initial mandate through ongoing compliance”
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Provides fast, responsive support from experienced regulatory professionals.
Source
“✓ Fast, responsive support from experienced regulatory professionals”
-
Ensures direct access to a dedicated regulatory contact, avoiding generic inboxes.
Source
“✓ Direct access to your dedicated regulatory contact (no generic inboxes)”
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Features transparent, flat-fee pricing with no hidden costs for EU AR services.
Source
“✓ Transparent, flat-fee pricing with no hidden costs”
Certifications & Trust Signals
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Specializes in medical device market access for Europe, the UK, and Switzerland.
Source
“Casus Consulting offers expert guidance for medical device market access in Europe, the UK, and Switzerland, specializing in regulatory compliance and registration.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking market access in the UK and Europe.
- Companies requiring assistance with regulatory compliance and registration processes.
How engagement typically works
- Direct access to dedicated regulatory contacts.
- Responsive support from experienced professionals.
- Transparent, flat-fee pricing.
Typical deliverables
- EU Authorized Representative services.
- UK Responsible Person services.
- MDR CE Marking support.
- IVDR CE Marking support.
- MHRA Device Registration assistance.
- UKCA Marking guidance.
Good to know
- Best when engaging for comprehensive market access support in the UK and Europe.
Pricing
Model:
Per project
HQ:
London, UK
Languages:
English
Timezones:
Europe/London
Status:
listed
Services & Capabilities
Best UK Responsible Person (UKRP) | Compare & Get Quotes
Jurisdictions:
UK
Countries:
GB
Industries:
Medical devices, IVD, Healthcare
Portfolio:
1-5, 6-25
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
GBP 1,600
Included services:
UK Responsible Person (UKRP) designation, MHRA liaison and communications forwarding, Support for registration process readiness, Vigilance escalation workflows and FSCA coordination, Labeling check for UKRP identification
Supports GB:
Yes
MHRA Support:
Yes
Can Be Named On Label:
Yes
MHRA Portal Support:
Yes
Vigilance Support:
Yes
Additional uk_rp Details
Supports MDR
Yes
Supports IVDR
Yes
Supports GB
Yes
UK Entity Country
England
Onboarding Steps
The EU AR service process is mentioned, involving initial mandate through ongoing compliance. Steps to market in Europe include obtaining CE Marking, appointing an EU Authorized Representative, registering company and devices, and identifying EU Importers. For the UK, steps include appointing a Responsible Person, MHRA Device Registration, and UKCA Marking.
Device Classes Supported
All
Vigilance Support
Yes
Post Market Support
Yes
