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**
* Facilitates Swiss market access for medical devices, managing product registration and distribution.
* Provides CE marking services, including expert assessment, workshops, and hands-on support for medical devices and in-vitro diagnostics.
* Offers regulatory and quality due diligence for mergers and acquisitions in the Medtech sector.
* Develops regulatory strategies and conducts gap analyses for medical devices.
* Supports compliance with new regulatory requirements, including the transition from IVDD to IVDR.
* Assists with the compilation of technical documentation and QMS (Quality Management System) establishment, adhering to EN ISO 13485 standards.
* Prepares Swiss importers for Swissmedic inspections with a structured Readiness Check, covering MedDO and IvDO compliance.
**Reputation / proof points**
* Operates under an ISO 13485 certified quality management system.
* Has supported over 100 medical device and in-vitro diagnostic companies, ranging from startups to large corporations.
* Experts possess extensive knowledge of Swiss regulations (MedDO/IvDO).
* Located in Switzerland, with a presence 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**
* Facilitates Swiss market access for medical devices, managing product registration and distribution.
* Provides CE marking services, including expert assessment, workshops, and hands-on support for medical devices and in-vitro diagnostics.
* Offers regulatory and quality due diligence for mergers and acquisitions in the Medtech sector.
* Develops regulatory strategies and conducts gap analyses for medical devices.
* Supports compliance with new regulatory requirements, including the transition from IVDD to IVDR.
* Assists with the compilation of technical documentation and QMS (Quality Management System) establishment, adhering to EN ISO 13485 standards.
* Prepares Swiss importers for Swissmedic inspections with a structured Readiness Check, covering MedDO and IvDO compliance.
**Reputation / proof points**
* Operates under an ISO 13485 certified quality management system.
* Has supported over 100 medical device and in-vitro diagnostic companies, ranging from startups to large corporations.
* Experts possess extensive knowledge of Swiss regulations (MedDO/IvDO).
* Located in Switzerland, with a presence on the campus of the University Hospital in Berne.
Additional information
Decomplix offers a comprehensive 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 short delivery times through local warehousing 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 by scheduling a call or requesting a quote to discuss specific needs and regulatory challenges.
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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Supports over 100 medical device and in-vitro diagnostic companies globally.
Source
“100+ medical device and in-vitro diagnostic companies of all shapes and sizes trust Decomplix”
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Offers a Readiness Check specifically designed to prepare for Swissmedic inspections.
Source
“Our Readiness Check gives you certainty and helps you avoid unpleasant surprises.”
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Provides comprehensive Swiss market access solutions, including acting as a registered Swiss Authorized Representative.
Source
“As a registered Swiss Authorized Representative, we manage your mandatory product registration.”
Certifications & Trust Signals
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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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Has supported 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”
Buyer Snapshot
Best for
- Medical device manufacturers seeking Swiss market access
- Companies needing CE marking and IVDR/MDR compliance support
- Businesses preparing for Swissmedic inspections
How engagement typically works
- Hands-on support tailored to individual needs
- Expert assessment and guidance
- Pragmatic and efficient solutions
Typical deliverables
- Swiss Authorized Representative services
- CE certification documentation
- Regulatory strategy and gap analysis reports
- Swissmedic inspection readiness reports
- Quality Management System (QMS) implementation
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
Discuss needs and questions via video call or request a quote; Joint planning of readiness checks; Provision of preparatory documents; Review of documentation through interviews and process assessment; Final report with findings and recommendations; 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 for medical devices and IVDs)
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 Swissmedic inspection readiness)
Can Be Named On Label
Yes (implied by acting as Swiss Authorized Representative)
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