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 specialized consultancy focused on medical device market access and regulatory compliance, particularly within Switzerland and the EU.
**Expertise & scope**
* Expert assessment for CE marking of medical devices, including interactive workshops and tailored support.
* Guidance on regulatory strategy, gap analyses, and transition from IVDD to IVDR.
* Support for CE marking of in-vitro diagnostic medical devices (IVDs) and medical device software.
* Regulatory and Quality Due Diligence for M&A in the Medtech sector.
* Preparation for Swissmedic inspections, including a structured Readiness Check simulating an inspection.
* Services for bringing medical devices to the Swiss market, including mandatory product registration as a Swiss Authorized Representative.
* Management of technical documentation, quality management systems (QMS) following EN ISO 13485, and conformity assessment routes.
**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 specialized consultancy focused on medical device market access and regulatory compliance, particularly within Switzerland and the EU.
**Expertise & scope**
* Expert assessment for CE marking of medical devices, including interactive workshops and tailored support.
* Guidance on regulatory strategy, gap analyses, and transition from IVDD to IVDR.
* Support for CE marking of in-vitro diagnostic medical devices (IVDs) and medical device software.
* Regulatory and Quality Due Diligence for M&A in the Medtech sector.
* Preparation for Swissmedic inspections, including a structured Readiness Check simulating an inspection.
* Services for bringing medical devices to the Swiss market, including mandatory product registration as a Swiss Authorized Representative.
* Management of technical documentation, quality management systems (QMS) following EN ISO 13485, and conformity assessment routes.
**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 offers a comprehensive solution for medical device manufacturers aiming for the Swiss market. This includes managing mandatory product registration as a Swiss Authorized Representative, ensuring compliance with local requirements. They also provide access to a local warehouse for short delivery times and leverage a qualified sales team familiar with Swiss culture and languages. Their services extend to developing reimbursement strategies and implementing strong marketing initiatives to promote devices effectively within the Swiss healthcare system. Buyers can engage Decomplix for end-to-end support, from initial regulatory strategy to ongoing market presence.
Key Highlights
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Operates under an ISO 13485 certified quality management system.
Source
“Decomplix operates under a ISO 13485 certified quality management system.”
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Trusted by over 100 medical device and in-vitro diagnostic companies.
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 market access.
Source
“As a registered Swiss Authorized Representative, we manage your mandatory product registration.”
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Offers a Readiness Check for Swissmedic inspections.
Source
“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 CE marking expertise
- Businesses preparing for Swissmedic inspections
How engagement typically works
- Hands-on support and expert assessment
- Tailored service and pricing
- Partnership for regulatory challenges
Typical deliverables
- CE certification documentation
- Swiss Authorized Representative services
- Readiness Check reports for Swissmedic inspections
- Regulatory strategy and gap analyses
Good to know
- Best when requiring specialized knowledge of Swiss medical device regulations.
Pricing
Model:
Custom pricing
HQ:
London, UK
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:
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
Swiss Entity Canton Or Region:
Bern (implied by location on University Hospital campus in Berne)
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
Involves joint planning of readiness checks, provision of preparatory documents, review of documentation through interviews, assessment of key processes, and joint development of an action plan.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
All 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 (implied by Swissmedic inspection readiness)
Can Be Named On Label
Yes (as Swiss Authorized Representative)
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