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. They offer expert guidance to streamline submissions, ensure compliance, and accelerate approvals.
**Expertise & scope**
* Develops regulatory affairs strategies to define workable plans for market authorization.
* Provides compliance services to ensure medical devices meet rigorous regulatory standards across various markets, including navigating MDR Article 117 for combination products and IVDR conformity.
* Offers support for market authorization in Europe, the USA, and other global markets.
* Specializes in design control, risk management, usability engineering, and clinical evaluation.
* Assists with CE marking and FDA registrations.
* Provides representation services for Switzerland (CH REP), the UK (UK REP), and the US (US AGENT to the FDA).
* Supports the role of the Person Responsible for Regulatory Compliance (PRRC).
* Drafts technical documentation files.
* Offers services related to EUDAMED and Swissdamed registration.
* Provides training and e-learning programs through the confinis Online Academy, covering topics like ISO 13485, AI in medical devices, cybersecurity, IEC 62304, clinical evaluation, and FDA regulatory pathways.
* Offers strategic business consulting and advanced data analytics.
**Reputation / proof points**
* Offices in Switzerland and the United States (Durham, NC).
* Global knowledge of market authorization requirements.
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.
**Expertise & scope**
* Develops regulatory affairs strategies to define workable plans for market authorization.
* Provides compliance services to ensure medical devices meet rigorous regulatory standards across various markets, including navigating MDR Article 117 for combination products and IVDR conformity.
* Offers support for market authorization in Europe, the USA, and other global markets.
* Specializes in design control, risk management, usability engineering, and clinical evaluation.
* Assists with CE marking and FDA registrations.
* Provides representation services for Switzerland (CH REP), the UK (UK REP), and the US (US AGENT to the FDA).
* Supports the role of the Person Responsible for Regulatory Compliance (PRRC).
* Drafts technical documentation files.
* Offers services related to EUDAMED and Swissdamed registration.
* Provides training and e-learning programs through the confinis Online Academy, covering topics like ISO 13485, AI in medical devices, cybersecurity, IEC 62304, clinical evaluation, and FDA regulatory pathways.
* Offers strategic business consulting and advanced data analytics.
**Reputation / proof points**
* Offices in Switzerland and the United States (Durham, NC).
* Global knowledge of market authorization requirements.
Additional information
confinis provides specialized support for startups, including tailored regulatory planning and efficient pathway design to accelerate market entry. Their confinis Online Academy offers comprehensive e-learning for the medical device industry, delivering practical, real-world learning from practicing experts. Courses are self-paced and cover complex regulatory frameworks such as FDA QMSR, ISO 13485, EUDAMED, Swissdamed, UK registrations, AI in medical devices, and cybersecurity. This platform is ideal for professionals and startups needing flexible, on-demand training to build competence and stay ahead of changing global requirements.
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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Offers representation services including CH REP, UK REP, and US AGENT to the FDA.
Source
“CH REP, UK REP, US AGENT to the FDA”
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Provides comprehensive e-learning and training programs through the confinis Online Academy.
Source
“The confinis Academy is a comprehensive e-learning platform tailored for the medical device industry.”
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Expertise includes navigating MDR Article 117 for combination products and IVDR conformity.
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”
Certifications & Trust Signals
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Global knowledge about market authorization requirements.
Source
“our global knowledge about market authorization requirements allow us to define a workable plan to achieve your goals.”
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Offices located in Switzerland and the United States.
Source
“Haupstrasse, 13186 DüdingenSwitzerland+41 (0) 26 494 84 94info.ch@confinis.com 600 Park Offices Drive Suite 300, Unit #50 Durham, NC 27709United States”
Buyer Snapshot
Best for
- Medical device manufacturers seeking regulatory and compliance support.
- Startups needing to accelerate market entry.
- Companies navigating complex regulations in Europe, the USA, and Switzerland.
How engagement typically works
- Consulting and expert guidance.
- E-learning and training programs.
- Representation services.
Typical deliverables
- Regulatory affairs strategy and market authorization plans.
- Compliance documentation and submissions (e.g., Technical Documentation Files, CE marking, FDA registrations).
- CH REP, UK REP, US AGENT services.
- EUDAMED and Swissdamed registration support.
- E-learning courses on regulatory and compliance topics.
Good to know
- Best when requiring specialized expertise in medical device regulatory affairs and compliance.
HQ:
Düdingen, 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:
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
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
Intake → mandate agreement → labeling/documentation check → Swiss workflows live
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
All device classes implied by comprehensive regulatory support for medical devices and combination products.
Supports MDR
true
Supports IVDR
true
Swiss Entity Canton Or Region
Düdingen, Switzerland
Labeling Support
true
Swiss Local Contact
true
Vigilance Contact Support
true
Can Be Named On Label
true
