confinis
Confinis is a global consulting firm specializing in regulatory affairs, compliance, and strategic market access for medical devices, diagnostics, and combination products. They offer expert guidance to streamline submissions, ensure compliance, and accelerate approvals.
Confinis is a global consulting firm with expertise in medical devices, in vitro diagnostics, and combination products, based in Switzerland and the USA. They specialize in helping clients navigate complex regulatory landscapes to achieve market authorization and ensure compliance. Their services encompass a wide range of regulatory affairs, including strategy development, market authorization requirements, and representation services (CH REP, UK REP, US AGENT to the FDA). Confinis also provides comprehensive compliance support, covering areas such as MDR Article 117, IVDR conformity, design control, risk management, usability engineering, and clinical evaluation. They assist with CE marking, FDA registrations, and performance evaluations. Beyond basic compliance, Confinis offers services to optimize operational excellence and strategic success. This includes product development strategies, market entry planning, and tailored support for startups and SMEs. They also provide e-learning and training programs through the confinis Academy, covering topics like ISO 13485, EUDAMED, AI in medical devices, and cybersecurity. With a focus on pragmatic and workable solutions, Confinis leverages its practical experience and theoretical foundations to act as a trusted partner for clients seeking to streamline regulatory submissions, ensure product safety and efficacy, and accelerate time-to-market.
About
**Who they are**
confinis is a global consulting firm specializing in regulatory affairs, compliance, and strategic market access for medical devices, diagnostics, and combination products, with offices in Switzerland, the UK, and the USA. They are recognized as a reputable Swiss regulatory consulting firm globally.
**Expertise & scope**
* Expert guidance to streamline submissions, ensure compliance, and accelerate approvals.
* Navigating complex regulatory landscapes including MDR Article 117 for combination products and IVDR conformity.
* Support for market authorization in Europe, the USA, and other global markets.
* Specialization in design control, risk management, usability engineering, and clinical evaluation.
* Services include CE marking, FDA registrations, performance evaluations, and software considerations.
* Representation services such as Swiss Authorized Representative (CH REP), UK Responsible Person (UK RP), and US Agent to the FDA.
* Development of regulatory affairs strategy and definition of workable plans for market authorization.
* Support for startups with tailored regulatory planning and efficient pathway design.
* E-learning and training programs on regulatory and compliance topics.
* Expertise in AI and cybersecurity for medical devices.
**Reputation / proof points**
* Offices in Switzerland, the UK, and the USA.
* Mastered regulatory theory and operates as practitioners with decades of experience.
* Managed every phase from concept to commercialization, ensuring rapid market authorization for over 2,000 devices.
confinis is a global consulting firm specializing in regulatory affairs, compliance, and strategic market access for medical devices, diagnostics, and combination products, with offices in Switzerland, the UK, and the USA. They are recognized as a reputable Swiss regulatory consulting firm globally.
**Expertise & scope**
* Expert guidance to streamline submissions, ensure compliance, and accelerate approvals.
* Navigating complex regulatory landscapes including MDR Article 117 for combination products and IVDR conformity.
* Support for market authorization in Europe, the USA, and other global markets.
* Specialization in design control, risk management, usability engineering, and clinical evaluation.
* Services include CE marking, FDA registrations, performance evaluations, and software considerations.
* Representation services such as Swiss Authorized Representative (CH REP), UK Responsible Person (UK RP), and US Agent to the FDA.
* Development of regulatory affairs strategy and definition of workable plans for market authorization.
* Support for startups with tailored regulatory planning and efficient pathway design.
* E-learning and training programs on regulatory and compliance topics.
* Expertise in AI and cybersecurity for medical devices.
**Reputation / proof points**
* Offices in Switzerland, the UK, and the USA.
* Mastered regulatory theory and operates as practitioners with decades of experience.
* Managed every phase from concept to commercialization, ensuring rapid market authorization for over 2,000 devices.
Additional information
confinis offers comprehensive support for medical device manufacturers aiming for global market access. Their services extend to acting as the Swiss Authorized Representative (CH REP), UK Responsible Person (UK RP), and US Agent, demonstrating a commitment to regulatory excellence. They provide expert guidance on navigating complex regulations from concept to commercialization, ensuring rapid market authorization. For those seeking to enhance their team's knowledge, confinis provides tailored e-learning and training programs covering a wide range of regulatory and compliance topics, including AI and cybersecurity for medical devices. Their approach emphasizes practical, real-world learning derived from extensive industry experience.
Key Highlights
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Specializes in regulatory affairs, compliance, and strategic market access for medical devices, diagnostics, and combination products.
Source
“global consulting firm specializing in regulatory affairs, compliance, and strategic market access for medical devices, diagnostics, and combination products.”
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Provides representation services including Swiss Authorized Representative (CH REP), UK Responsible Person (UK RP), and US Agent.
Source
“Our services extend as the Swiss Authorized Representative (CH REP), the UK Responsible Person (UK RP) and the US Agent”
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Offers comprehensive support for navigating MDR Article 117, IVDR conformity, and market authorization in Europe and the USA.
Source
“Whether you are navigating the complexities of MDR Article 117 for combination products, aiming for IVDR conformity, or seeking market authorization in Europe, the USA, or other global markets”
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Provides tailored e-learning and training programs through the confinis Online Academy for regulatory and compliance learning.
Source
“The confinis Academy is a comprehensive e-learning platform tailored for the medical device industry.”
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Has successfully managed market authorization for over 2,000 devices from concept to commercialization.
Source
“we expertly manage every phase from concept to commercialization, ensuring rapid market authorization for over 2,000 devices.”
Certifications & Trust Signals
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Established presence with offices in Switzerland, the UK, and the USA.
Source
“With offices in Switzerland, the UK, and the USA, confinis is strategically located to best assist you”
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Recognized as a reputable Swiss regulatory consulting firm globally.
Source
“confinis stands as the most reputable Swiss regulatory consulting firm globally”
Buyer Snapshot
Best for
- Medical device, diagnostic, and combination product manufacturers
- Companies seeking market authorization in Europe, USA, and other global markets
- Startups and scale-ups needing regulatory planning and market access support
How engagement typically works
- Consulting and expert guidance
- Representation services (CH REP, UK RP, US Agent)
- E-learning and training programs
Typical deliverables
- Regulatory affairs strategy and market authorization plans
- Technical documentation files
- Compliance support (MDR, IVDR, FDA)
- CH REP, UK RP, US Agent services
- E-learning modules and training programs
Good to know
- Best when requiring specialized regulatory and compliance expertise for medical devices.
HQ:
Düdingen, Switzerland
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
26-100
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
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:
Yes
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Swiss Entity Canton Or Region:
Düdingen, Switzerland
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
Onboarding involves submitting details for a call, and specific services like EUDAMED/Swissdamed registration support are offered. The confinis Online Academy provides self-paced modules for continuous upskilling.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Class I, IIa, IIb, III
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
Düdingen, Switzerland
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
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