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**
* Guidance on streamlining submissions
* Ensuring compliance with regulations
* Accelerating product approvals
* Expertise in medical devices, diagnostics, and combination products
**Reputation / proof points**
* Global presence
confinis is a global consulting firm specializing in regulatory affairs, compliance, and strategic market access for medical devices, diagnostics, and combination products.
**Expertise & scope**
* Guidance on streamlining submissions
* Ensuring compliance with regulations
* Accelerating product approvals
* Expertise in medical devices, diagnostics, and combination products
**Reputation / proof points**
* Global presence
Additional information
confinis provides expert guidance to navigate the complexities of regulatory affairs and market access. Their focus on medical devices, diagnostics, and combination products means they understand the specific challenges buyers face in bringing these products to market. Buyers can expect a strategic approach aimed at efficient submissions and accelerated approvals, ensuring compliance throughout the process.
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 compliance services for MDR Article 117 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, our expert team provides comprehensive support.”
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Operates the confinis Online Academy, an e-learning platform for regulatory and compliance learning in the medical device industry.
Source
“Your Online Platform for Regulatory and Compliance Learning! The confinis Academy is a comprehensive e-learning platform tailored for the medical device industry.”
Certifications & Trust Signals
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Has offices in the Washington DC area, Düdingen, Switzerland, and Durham, NC, 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 +1 910 228 9391info.usa@confinis.com”
Buyer Snapshot
Best for
- Medical device manufacturers seeking regulatory and market access support
- Companies dealing with diagnostics and combination products
- Businesses needing to streamline submissions and accelerate approvals
How engagement typically works
- Expert guidance
- Strategic market access support
- Compliance consulting
Typical deliverables
- Streamlined submission strategies
- Compliance assurance plans
- Accelerated approval pathways
Good to know
- Best when requiring specialized knowledge in medical devices, diagnostics, and combination products.
HQ:
Düdingen, Switzerland
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
Find 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
The confinis Online Academy offers courses on topics like ISO 13485 implementation for startups, suggesting a focus on practical system setup and regulatory approval processes.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Not explicitly stated, but services cover MDR and IVDR which apply to various classes.
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
CH
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
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