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 workshops and tailored support.
* Guidance on transitioning from IVDD to IVDR and CE marking of in-vitro diagnostic medical devices.
* Development and maintenance of Quality Management Systems (QMS) compliant with EN ISO 13485.
* Compilation of technical documentation demonstrating compliance with General Safety and Performance Requirements (GSPRs).
* Support for regulatory and quality due diligence in Medtech M&A projects.
* Assistance with regulatory strategy and gap analyses for medical devices.
* Preparation for Swissmedic inspections, including a structured Readiness Check.
* Acting as a registered Swiss Authorized Representative, managing mandatory product registration.
* Providing solutions for medical software regulatory challenges.
**Reputation / proof points**
* Operates under an ISO 13485 certified quality management system.
* Has supported 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 workshops and tailored support.
* Guidance on transitioning from IVDD to IVDR and CE marking of in-vitro diagnostic medical devices.
* Development and maintenance of Quality Management Systems (QMS) compliant with EN ISO 13485.
* Compilation of technical documentation demonstrating compliance with General Safety and Performance Requirements (GSPRs).
* Support for regulatory and quality due diligence in Medtech M&A projects.
* Assistance with regulatory strategy and gap analyses for medical devices.
* Preparation for Swissmedic inspections, including a structured Readiness Check.
* Acting as a registered Swiss Authorized Representative, managing mandatory product registration.
* Providing solutions for medical software regulatory challenges.
**Reputation / proof points**
* Operates under an ISO 13485 certified quality management system.
* Has supported 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 approach to entering the Swiss market, managing all aspects from product registration to distribution. They emphasize understanding local requirements and cultural nuances to ensure commercial success. For manufacturers seeking to establish a presence in Switzerland, Decomplix provides a complete solution, including managing mandatory product registration as a registered Swiss Authorized Representative. Their services extend to local warehousing for short delivery times and utilizing a qualified sales team familiar with Swiss culture and languages. They also assist with reimbursement strategies and marketing to promote devices effectively within the Swiss healthcare system.
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 to prepare 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 and regulatory strategy support.
- Businesses preparing for Swissmedic inspections.
How engagement typically works
- Hands-on support and expert assessment.
- Tailored services and pricing based on individual needs.
- Partnership for navigating complex regulatory landscapes.
Typical deliverables
- CE certification documentation.
- Quality Management System (QMS) implementation.
- Swiss Authorized Representative services.
- Swissmedic inspection readiness reports.
- Technical documentation compilation.
Good to know
- Best when requiring specialized expertise in Swiss medical device regulations.
Pricing
Model:
Custom pricing
HQ:
London, UK
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:
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, simulation of inspections, review of documentation through interviews, and development of action plans.
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 (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 (implied by Swiss market access services)
Swiss Local Contact
Yes
Vigilance Contact Support
Yes (implied by Swiss Authorized Representative role and Swissmedic inspection prep)
Can Be Named On Label
Yes (implied by Swiss Authorized Representative role)
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