decomplix

What decomplix does

Decomplix AG is a privately held Swiss regulatory and quality management consulting firm headquartered in Bern that helps medical device and in-vitro diagnostic (IVD) manufacturers navigate EU and Swiss compliance requirements. Its core service lines are CE marking support for EU market access, Swiss Authorised Representative (CH-REP) services for foreign manufacturers entering the non-EU-aligned Swiss market, consulting and templates for Swiss importers under MedDO and IvDO, Swissmedic inspection readiness, and, through a strategic partnership with Evidencio, certification of customer algorithms as CE-marked medical device software in under a year. The firm holds ISO 13485 certification (valid until May 2029) and passed a Swissmedic inspection as CH-REP with no non-conformities in April 2022.

The company operates a professional services model with customized fixed pricing tied to each customer's needs, typically structured around multi-year contracts for ongoing CH-REP mandates. Decomplix is sales-led, generating demand through content marketing (regulatory blog, newsletter), SEO, and direct website inquiry forms. It targets a horizontal segment across medical device manufacturers of all sizes — from startups (Rikai, nahtlos, NeuroPro) to multinationals (Cook Medical, SD Biosensor, Groupe Mutuel, Sanitas) — as well as Swiss importers, healthcare institutions, and government entities (FOPH/SwissCovid App).

Decomplix AG is led by CEO Beni Hirt, Regulatory Affairs Director Helena Lacalle, and a board that includes former ISS AG CEO Hansjörg Riedwyl and Professor Rudolf Blankart of the University of Bern. The firm employs 10-11 senior regulatory and quality consultants and runs an ecosystem of partnerships with academic (sitem-insel, ZHAW), legal (Beutler Künzi Stutz), cloud (netrics), and innovation (Creaholic, Congenius, ISS AG) organizations. No external funding, M&A activity, or ownership changes are disclosed.

Name

decomplix

Legal name

Decomplix AG

Website

https://decomplix.com

Company type

Private

Operating status

Operating

Headcount range

1–10 employees

Short description

Decomplix is a Bern-based Swiss regulatory and quality management consulting firm that helps medical device and IVD manufacturers achieve CE marking, Swiss market access via CH-REP representation, and import compliance under Swissmedic oversight.

Ownership category

akta.pro rank

Product category

Medical Device Regulatory Compliance Consulting

akta.pro primary industry

Import/Export Controls, Supply Chain Integrity & Anti-Counterfeiting (HLAJADAJ)

Keywords

• Medical device compliance
• Regulatory affairs consulting
• CE marking services
• CH-REP services
• Swiss market access

Headquarters

HQ city

Bern

HQ country

Switzerland

HQ region

Europe

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Marketing or Sales, Technology or R&D

Revenue model

1. Regulatory Consulting Services: Professional consulting services for CE marking, regulatory affairs, and quality management for medical devices and IVDs. Services are tailored to customer needs with fixed pricing.
2. Swiss Authorised Representative (CH-REP) Mandate: As CH-REP, Decomplix acts as official representative for foreign manufacturers in Switzerland, providing ongoing regulatory compliance services.
3. Swiss Importer Services: Consulting and support services for Swiss medical device importers including training, templates, and inspection readiness checks.

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels4 records

Core offering

Decomplix provides regulatory affairs and quality management consulting services for medical device and in-vitro diagnostic manufacturers. Core offerings include CE Marking Services for EU market access, Swiss Authorised Representative (CH-REP) services enabling foreign manufacturers to access the Swiss market, CH Import consulting for compliant importation of medical devices into Switzerland, Swissmedic inspection readiness preparation, and medical device software certification through the Evidencio partner platform.

Product overview

Decomplix is a regulatory consulting firm offering a portfolio of compliance services for medical device and in-vitro diagnostic companies. The core offering includes CE Marking Services for EU market access, CH-REP (Swiss Authorised Representative) services for Switzerland, and CH Import consulting for Swiss importers. Additional services include Swissmedic Inspection Readiness and Medical Device Software Certification through partnership with Evidencio. The company provides hands-on regulatory affairs support, quality management consulting, and compliance tools including templates and checklists. Decomplix serves 100+ medical device and IVD companies ranging from startups to corporates.

Differentiator

Problem solved

Functional benefit

Products and services

• CE Marking Services Expert guidance and hands-on support through medical device CE certification processes under EU MDR and IVDR. The service delivers regulatory affairs and quality management support to ensure regulatory compliance and EU market access for medical devices and IVDs.
• CH-REP (Swiss Authorised Representative) Decomplix acts as the official Swiss Authorised Representative (CH-REP) for foreign medical device manufacturers, enabling legal market access to Switzerland. Compliance was confirmed by a Swissmedic inspection in April 2022 with no non-conformities identified.
• CH Import Services Consulting, training, and ready-to-use templates for procedures, checklists and tools enabling compliant importation of medical devices into Switzerland. Services are tailored to client needs at fixed price.
• Swissmedic Inspection Readiness Expert preparation services helping Swiss medical device importers pass Swissmedic inspections for compliance with MedDO and IvDO, preventing business interruption.
• Medical Device Software Certification (Evidencio Partnership) Through the Evidencio partner platform, Decomplix transforms algorithms and clinical software into CE-certified medical device software (MDSW) in less than a year, offering a fast, proven, de-risked certification path.
• Regulatory Affairs Consulting Expert regulatory consulting services including quality management system (QMS) support, compliance consulting, and regulatory strategy development for medical devices and in-vitro diagnostics.

Quantifiable outcome

• 100+ medical device and IVD companies trust Decomplix
• +2 more outcomes

Named customers15 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Seven partnerships are on record, tiered core and minor.

• EvidenciocoreStrategic or Co-development PartnerEvidencio is a partner platform that enables fast and cost-efficient market access for clinical algorithms as legal manufacturer. Through the Evidencio platform, Decomplix customers' software algorithms can be transformed into CE-certified medical device software (MDSW) in a simple and scalable way.
• sitem-insel AGminorStrategic or Co-development Partnersitem-insel AG aims to facilitate the application of research results in medicine (translation). They provide researchers with education, consulting and infrastructure, and offer Decomplix access to important clinical areas.
• ZHAW (Zürcher Hochschule für Angewandte Wissenschaften)minorStrategic or Co-development PartnerZHAW offers practice-oriented study programs as well as application-oriented research and development. The Center for Safety-Critical Systems supports Decomplix with regulatory expertise.
• Beutler Künzi Stutz AGminorImplementation/ SI/ Consulting PartnerLegal specialists for Decomplix. Customers benefit from their knowledge and experience in data protection, intellectual property and information technology.
• CreaholicminorStrategic or Co-development PartnerInnovation factory specializing in inventions and innovation culture. They are makers and prototypers, complementing Decomplix when it comes to launching new products or business models.
• Congenius AGminorImplementation/ SI/ Consulting PartnerService provider for regulatory affairs and quality management, extending Decomplix's workbench for QMS setups for customers and bringing specific regulatory and clinical knowledge.
• ISS AG (Integrated Scientific Services)minorImplementation/ SI/ Consulting PartnerISS AG's team secures extensive knowledge and experience in medical device software development, quality management, clinical and regulatory affairs.

Scale indicators1 record

Recent moves6 records

Expansion highlights5 records

Direct peers

• Johner Institute: German regulatory and quality consultancy focused on medical device software, AI/MDSW, and IEC 62304/ISO 13485. Directly overlaps with Decomplix's CE marking and SaMD certification practices, especially for DACH-region digital health clients.
• Qserve Group: European regulatory and quality consulting firm for medical devices and IVDs with offices in the Netherlands, Germany, and the US. Direct competitor for MDR/IVDR compliance, Notified Body interactions, and CH-REP-adjacent work.
• RQM+: Global medical device regulatory and quality consulting firm (formerly R&Q). Competes head-to-head on CE marking, IVDR readiness, and regulatory strategy for medtech manufacturers worldwide.
• Medidee Services SA: Swiss-headquartered regulatory affairs, clinical, and quality consultancy serving medical device and IVD manufacturers across the EU. Direct competitor for CE marking, IVDR, MDR, and clinical strategy mandates.
• ISS AG (Integrated Scientific Services): Swiss medical device software and regulatory affairs consultancy. Directly comparable to Decomplix in scope (MDSW, QMS, RA), shares former CEO Hansjörg Riedwyl with Decomplix, and is an explicit implementation partner of Decomplix.
• Congenius AG: Swiss regulatory affairs and quality management service provider. Listed as a Decomplix implementation partner that extends QMS capabilities; competes for the same SMB and startup MedTech clients in Switzerland.

Emerging players

• Evidencio: Platform for creating and CE-certifying clinical prediction algorithms as medical device software. Direct strategic partner of Decomplix for fast-track SaMD certification; could also be considered a partial competitor in the SaMD enablement layer.

Others

• Creaholic: Swiss innovation factory and prototyping consultancy listed as a Decomplix partner. Not a direct competitor but provides adjacent innovation, prototyping, and product-launch services to many of the same medtech startup clients.

Broad incumbents

• BSI Group (Medical Devices): UK-headquartered Notified Body issuing CE marks under MDR/IVDR. Broad incumbent in medical device certification that competes indirectly by offering bundled regulatory and quality services to manufacturers Decomplix also serves.
• TÜV SÜD (Healthcare & Medical Devices): Global Notified Body and testing/certification conglomerate. Larger incumbent competing for the same CE marking, ISO 13485, and MDSW certification engagements, but operating across many industries beyond Decomplix's narrow MedTech focus.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/decomplix

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about decomplix