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.
**Expertise & scope**
* Develops regulatory affairs strategies to define workable plans for market authorization.
* Provides compliance services to ensure medical devices meet rigorous regulatory standards, including 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 services that go beyond basic compliance to optimize operational excellence and strategic success.
* Offers specialized support for startups, including tailored regulatory planning and efficient pathway design.
* Develops comprehensive e-learning and training programs.
* Provides strategic business consulting and advanced data analytics.
* Offers representation services for Switzerland (CH REP), the UK (UK REP), and the US (US AGENT to the FDA).
* Assists with EUDAMED and swissdamed registration.
* Supports the role of the Person Responsible for Regulatory Compliance (PRRC).
* Specializes in drafting technical documentation files.
* Provides support for clinical investigations and evidence strategies.
* Assists with writing sections of eCTD for submissions in the US and EU.
* Offers evaluation and monitoring of applicable regulations, standards, and guidances.
* Provides liaison with testing labs, labeling, UDI support, and supplier evaluation for drug delivery systems.
* Defines reprocessing strategies and conducts QMS gap analysis and implementation.
* Performs risk management according to ISO 14971 and conducts design reviews.
* Offers human factors threshold analyses and design history file creation.
* Provides services related to AI in medical devices, cybersecurity, and product strategy.
**Reputation / proof points**
* Has offices in the Washington DC area.
* Has an office in Düdingen, Switzerland.
* Has an office in Durham, NC, United States.
confinis is a global consulting firm specializing in regulatory affairs, compliance, and strategic market access for medical devices, diagnostics, and combination products.
**Expertise & scope**
* Develops regulatory affairs strategies to define workable plans for market authorization.
* Provides compliance services to ensure medical devices meet rigorous regulatory standards, including 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 services that go beyond basic compliance to optimize operational excellence and strategic success.
* Offers specialized support for startups, including tailored regulatory planning and efficient pathway design.
* Develops comprehensive e-learning and training programs.
* Provides strategic business consulting and advanced data analytics.
* Offers representation services for Switzerland (CH REP), the UK (UK REP), and the US (US AGENT to the FDA).
* Assists with EUDAMED and swissdamed registration.
* Supports the role of the Person Responsible for Regulatory Compliance (PRRC).
* Specializes in drafting technical documentation files.
* Provides support for clinical investigations and evidence strategies.
* Assists with writing sections of eCTD for submissions in the US and EU.
* Offers evaluation and monitoring of applicable regulations, standards, and guidances.
* Provides liaison with testing labs, labeling, UDI support, and supplier evaluation for drug delivery systems.
* Defines reprocessing strategies and conducts QMS gap analysis and implementation.
* Performs risk management according to ISO 14971 and conducts design reviews.
* Offers human factors threshold analyses and design history file creation.
* Provides services related to AI in medical devices, cybersecurity, and product strategy.
**Reputation / proof points**
* Has offices in the Washington DC area.
* Has an office in Düdingen, Switzerland.
* Has an office in Durham, NC, United States.
Additional information
confinis provides a comprehensive online academy for regulatory and compliance learning, tailored for the medical device industry. Their courses are designed to empower professionals and startups by translating complex regulatory frameworks into practical, real-world learning. Topics covered include ISO 13485 compliance for startups, EUDAMED, Swissdamed, and UK registration, challenges of AI integration and cybersecurity in medical devices, IEC 62304 software development, clinical evaluation, and FDA regulatory pathways. These self-paced modules, case-based examples, and access to exclusive consulting offers support continuous upskilling for regulatory, quality, clinical, and product teams.
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 for Switzerland (CH REP), the UK (UK REP), and the US (US AGENT to the FDA).
Source
“offer representation services for Switzerland (CH REP), the...”
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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
“navigating the complexities of MDR Article 117 for combination products, aiming for IVDR conformity”
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Supports startups with tailored regulatory planning and efficient pathway design to accelerate market entry.
Source
“Our specialized support for startups includes tailored regulatory planning and efficient pathway design to accelerate market entry.”
Certifications & Trust Signals
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Has offices in Switzerland, the United States (North Carolina), and a presence in the Washington DC area.
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 expertise.
- Startups requiring tailored regulatory planning and market access strategies.
- Companies needing representation in Switzerland, the UK, or the US.
How engagement typically works
- Consulting and expert guidance.
- E-learning and training programs.
- Representation services.
Typical deliverables
- Regulatory affairs strategy and market authorization plans.
- Technical documentation files.
- QMS gap analysis and implementation.
- CH REP, UK REP, US AGENT services.
- EUDAMED and swissdamed registration support.
- Training materials and e-learning courses.
Good to know
- Best when requiring specialized knowledge in medical device regulations across global markets.
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 the confinis Online Academy offers self-paced modules with case-based examples 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
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
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