Decomplix
Taylor & Francis Group
Decomplix, powered by Taylor & Francis, offers specialized digital hubs for medical and scientific professionals, providing access to journals, research, and community forums.
Decomplix, operating under the umbrella of Taylor & Francis Group, is a provider of specialized digital platforms designed for medical and scientific professionals. These platforms, such as Medical Devices Zone and Bioanalysis Zone, serve as comprehensive resources for accessing the latest research, news, and discussions within specific fields. They feature a wealth of content including journal articles, eBooks, webinars, expert commentaries, and community forums, fostering collaboration and knowledge sharing. Taylor & Francis, a leading academic publisher with over two centuries of experience, is committed to making high-quality research accessible globally. With a presence in 14 countries and a vast portfolio of over 180,000 book titles and 2,700 journals, they support a diverse community of experts, researchers, and knowledge makers. Their purpose is to foster human progress through knowledge, ensuring that trusted information accelerates and maximizes the impact of scholarly work.
About
**Who they are**
Decomplix is a Swiss-based regulatory consultancy specializing in medical device market access, particularly for the Swiss market. They offer comprehensive solutions for manufacturers seeking to navigate the Swiss healthcare system and its specific regulatory framework.
**Expertise & scope**
* CE marking services for medical devices, including in-vitro diagnostics (IVDs).
* Support for transitioning from IVDD to IVDR.
* Regulatory and Quality Due Diligence for M&A in Medtech.
* Medical software compliance solutions.
* Swiss Authorized Representative services, managing mandatory product registration.
* Preparation for Swissmedic inspections, including a structured Readiness Check.
* Guidance on Swiss market access, distribution, and commercial success.
* Expert assessment of regulatory situations with interactive workshops and flat-rate pricing.
**Reputation / proof points**
* Operates under an ISO 13485 certified quality management system.
* Trusted by over 100 medical device and in-vitro diagnostic companies globally.
* Experts possess extensive knowledge of Swiss regulations (MedDO/IvDO).
* Located in the center of Switzerland on the campus of the University Hospital in Berne.
Decomplix is a Swiss-based regulatory consultancy specializing in medical device market access, particularly for the Swiss market. They offer comprehensive solutions for manufacturers seeking to navigate the Swiss healthcare system and its specific regulatory framework.
**Expertise & scope**
* CE marking services for medical devices, including in-vitro diagnostics (IVDs).
* Support for transitioning from IVDD to IVDR.
* Regulatory and Quality Due Diligence for M&A in Medtech.
* Medical software compliance solutions.
* Swiss Authorized Representative services, managing mandatory product registration.
* Preparation for Swissmedic inspections, including a structured Readiness Check.
* Guidance on Swiss market access, distribution, and commercial success.
* Expert assessment of regulatory situations with interactive workshops and flat-rate pricing.
**Reputation / proof points**
* Operates under an ISO 13485 certified quality management system.
* Trusted by over 100 medical device and in-vitro diagnostic companies globally.
* Experts possess extensive knowledge of Swiss regulations (MedDO/IvDO).
* Located in the center of Switzerland on the campus of the University Hospital in Berne.
Additional information
Decomplix provides a complete solution for medical device manufacturers aiming to enter the Swiss market. This includes managing mandatory product registration as a registered Swiss Authorized Representative. They emphasize their local expertise in navigating Swiss regulatory frameworks and requirements, ensuring secure distribution and long-term commercial success. Their services are tailored to individual needs, offering hands-on support and pragmatic solutions. Buyers can engage through a video call to discuss specific needs or request a quote, with a focus on simplifying and speeding up the market access process.
Key Highlights
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Decomplix operates under an ISO 13485 certified quality management system.
Source
“Decomplix operates under a ISO 13485 certified quality management system.”
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Over 100 medical device and in-vitro diagnostic companies trust Decomplix.
Source
“100+ medical device and in-vitro diagnostic companies of all shapes and sizes trust Decomplix”
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Provides Swiss Authorized Representative services for mandatory product registration.
Source
“As a registered Swiss Authorized Representative, we manage your mandatory product registration.”
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Offers a Readiness Check service to prepare for Swissmedic inspections.
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“Our Readiness Check gives you certainty and helps you avoid unpleasant surprises.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Medical device manufacturers seeking Swiss market access.
- Companies needing a Swiss Authorized Representative.
- Firms preparing for Swissmedic inspections.
How engagement typically works
- Hands-on support from experts.
- Tailored services and pricing.
- Interactive workshops.
Typical deliverables
- Swiss Authorized Representative services.
- CE marking documentation and strategy.
- Swissmedic inspection readiness reports.
- Technical documentation compilation.
- Quality Management System (QMS) establishment.
Good to know
- Best when requiring specialized knowledge of Swiss medical device regulations (MedDO/IvDO).
Pricing
Model:
Custom pricing
HQ:
London, UK
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:
6-25
Onboarding time:
3–10 days
Pricing model:
Custom pricing
Starting from:
CHF 1,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III
Swiss Local Contact:
Yes
Labeling Support:
Yes
Vigilance Contact Support:
Yes
Can Be Named On Label:
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
1. Initial contact to discuss needs and questions. 2. Expert assessment of the situation, potentially including interactive workshops. 3. Tailoring of services and pricing to individual needs. 4. Provision of preparatory documents for specific checks (e.g., Swissmedic inspection).
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 CE marking services)
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
Bern (implied by location on University Hospital campus in Berne)
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
