Effectum Medical
Effectum Medical AG is a Swiss MedTech regulatory services firm that acts as an outsourced Legal Manufacturer and provides a pre-built, ISO 13485 / MDR / IVDR-compliant Plug & Play QMS, enabling startups, growth-stage companies, and pharmaceutical firms to achieve fast-track CE certification across EU, UK, USA, and APAC markets.
- Company typePrivate
- Founded2017
- HeadquartersOlten, Switzerland
- Headcount11–50
- GTM typeB2B
- OfferingServices
What Effectum Medical does
Effectum Medical AG is a Swiss MedTech regulatory services company headquartered in Olten, Switzerland, founded in 2017. It operates as an outsourced Legal Manufacturer and Quality Management System (QMS) provider for medical device innovators, enabling rapid CE-marking under the EU MDR/IVDR framework. The company's core technology is a pre-built, audit-proven ISO 13485 / MDR / IVDR / FDA-compliant QMS — the so-called "Plug & Play QMS" — delivered either through a cloud-based electronic QMS platform (Qualio) or via SharePoint-based document management, and packaged with ready-to-use SOPs, templates, and on-demand customization. Effectum holds its own EN ISO 13485:2016 certifications for Medical Devices (via DQS, 2024) and In-Vitro Diagnostics (via mdc), and operates an established Notified Body relationship with SGS that enables fast-track certification for clients.
The company generates revenue through five service lines: Outsourced Legal Manufacturer (professional service fees for acting as manufacturer-of-record), Plug & Play QMS subscriptions (recurring revenue), Rent an Expert (on-demand QA/RA consultants), Regulatory Opinions (expert classification and pathway reports), and AI/ML Expert services (specialized certification guidance for AI-driven devices under MDR, IVDR, and the EU AI Act). Pricing is fully quote-based with no public tiers; engagements typically span multi-year contracts. The go-to-market is a sales-led, enterprise field motion targeting MedTech startups, growth-stage companies, SMEs, and global pharmaceutical companies across Switzerland, the EU, the UK, the USA, Japan, and Australia, supplemented by an extensive partner network with accelerators and innovation hubs (Venture Kick, Swiss Healthcare Startups, RUNWAY, DayOne, HealthTech Park Zurich-Schlieren, Luxinnovation, and others).
The customer base spans over 40 named logos, predominantly early-stage MedTech startups (Aspivix, Biospectal, Distalmotion, Hemotune, Hylomorph, machineMD, Perivision, Sleepiz, CompagOS, Pipra) plus selected enterprise accounts (mediQ/PDAG, Mathys, Signus Medizintechnik, Global Supplier for Pharma). In March 2025, the company divested its Swiss Authorized Representative subsidiary (Effectum CH-Rep AG) to Healthcare Holding Schweiz AG to concentrate fully on Legal Manufacturing and QMS-as-a-Service offerings. Effectum is privately held and founder-controlled (CEO/Co-Founder Karina Candrian), with no disclosed external venture capital or private equity funding.
Effectum Medical firmographics
Firmographics- Name
- Effectum Medical
- Legal name
- Effectum Medical AG
- Website
- https://effectummedical.com
- Company type
- Private
- Founded year
- 2017
- Operating status
- Operating
- Headcount range
- 11–50 employees
- Short description
- Effectum Medical AG is a Swiss MedTech regulatory services firm that acts as an outsourced Legal Manufacturer and provides a pre-built, ISO 13485 / MDR / IVDR-compliant Plug & Play QMS, enabling startups, growth-stage companies, and pharmaceutical firms to achieve fast-track CE certification across EU, UK, USA, and APAC markets.
- Ownership category
- akta.pro rank
Effectum Medical industry classification
Industry- Product category
- MedTech Regulatory Services
- NAICS
- Other Scientific and Technical Consulting Services (54169), Other Scientific and Technical Consulting Services (541690)
- SIC
- Services-Commercial Physical & Biological Research (8731), Services-Testing Laboratories (8734)
- akta.pro primary industry
- Quality Management Systems (QMS) & GxP Documentation (HLAGAKAD)
- akta.pro secondary industries
- Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA) (HLAGAKAJ), Regulatory Strategy & Global Submissions (IND/CTA/NDA/BLA/MAA) (HLAGAKAA), Third-Party/Outsourced Quality & Responsible Person Services (EU QP/RP, US Agent) (HLAGAKAO)
Keywords
Where Effectum Medical is headquartered
LocationHeadquarters
- HQ city
- Olten
- HQ country
- Switzerland
- HQ region
- Europe
Offices1 record
Markets served
Effectum Medical business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Personnel, Technology or R&D, Marketing or Sales, Operations, Others
Revenue model
- Legal Manufacturer Services: Effectum acts as Swiss-based legal manufacturer enabling rapid CE-marking under MDR/IVDR. Includes QMS, Notified Body coordination (SGS), vigilance, post-market surveillance, PRRC services, and label ownership. Revenue from professional service fees for acting as manufacturer-of-record.
- Plug & Play QMS Subscription: Subscription-based access to pre-built QMS with SOPs, templates, and eQMS software integration. Includes on-demand customization, training, QMS management, documentation reviews, and PRRC/QMR services.
- Rent an Expert: On-demand access to qualified MedTech professionals for QMS, RA, software validation, audits, documentation. Flexible project-based or ongoing support.
- Regulatory Opinions: Expert-written reports on classification, applicable standards, and approval routes for internal alignment and fundraising support.
- AI/ML Expert Services: Specialized certification guidance for AI/ML medical devices under MDR, IVDR, and EU AI Act including gap analyses, regulatory strategy, CE certification, and lifecycle monitoring.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Multi-year contract | Custom professional services engagement |
Go-to-market motion2 records
Distribution channels3 records
Marketing channels4 records
Effectum Medical product offering
Product offeringCore offering
Effectum Medical AG is a Swiss MedTech regulatory services firm that enables medical device innovators to achieve CE-marking under MDR/IVDR by acting as their Outsourced Legal Manufacturer and providing pre-built ISO 13485-compliant Plug & Play Quality Management Systems, on-demand senior QA/RA consulting (Rent an Expert), Regulatory Opinions for classification and approval pathway analysis, and AI/ML Expert compliance services for AI-driven medical devices. The company combines QM infrastructure with advisory capacity to accelerate EU market entry for startups, SMEs, and global pharmaceutical companies.
Product overview
Effectum Medical is a Swiss MedTech regulatory services provider offering a portfolio of compliance solutions: the Outsourced Legal Manufacturer service enables CE-marking under their MDR-certified QMS with SGS Notified Body; the Plug & Play QMS provides a pre-built, cloud-based ISO 13485/MDR/IVDR/FDA-compliant system via Qualio or SharePoint; Rent an Expert delivers on-demand QA/RA consultants; Regulatory Opinions delivers expert classification and pathway analysis; and the AI/ML Expert service addresses compliance for AI-driven devices under MDR and the EU AI Act. The company also maintains an extended expert network for clinical, biocompatibility, validation, and software specialization.
Differentiator
Problem solved
Functional benefit
Products and services
- Outsourced Legal Manufacturer
Quantifiable outcome
- 12 months ahead of certification timeline
- +4 more outcomes
Companies that use Effectum Medical
Customer profileNamed customers40 records
Segments4 records
Ideal customer profiles4 records
Effectum Medical technology and API
TechnologyTechnology focussed No
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Integration1 record
AI capability3 records
Feature2 records
Effectum Medical partnerships and signals
Strategic signalPartnerships
18 partnerships are on record, tiered minor and core.
- Healthcare Holding Schweiz AGminorEffectum Medical sold its Swiss Authorized Representative subsidiary (Effectum CH-Rep AG) to Healthcare Holding Schweiz AG in March 2025. This transaction marks a carve-out of all services provided as Swiss CH-REP. Effectum Medical now focuses on Legal Manufacturing and Plug-and-Play QMS while continuing collaboration with Effectum CH-Rep for customer benefit.
- QualiocoreExclusive partnership providing Qualio-based eQMS to clients with special pricing. Qualio is the electronic Quality Management System software platform used for Effectum's Plug & Play QMS service. Clients can access Qualio through Effectum's partnership with exclusive pricing.
- Venture KickcorePartnership with Venture Kick, a Swiss startup funding organization. Multiple Effectum clients have participated in and won Venture Kick competitions with Effectum's regulatory guidance.
- SGS (Notified Body)coreSGS is Effectum Medical's Notified Body partner for MDR/IVDR certification. Effectum's established relationship with SGS enables 'fast track' certification for clients, significantly accelerating CE-marking timelines.
- Swiss Healthcare StartupscorePartnership with Swiss Healthcare Startups accelerator and innovation hub, providing regulatory services to member startups.
- RUNWAY Startup IncubatorcorePartnership with RUNWAY Startup Incubator in Switzerland for reaching early-stage MedTech innovators.
- DayOne (BaselArea.swiss)corePartnership with DayOne, the healthcare and biotech accelerator from BaselArea.swiss.
- HealthTech Park Zurich-SchlierencorePartnership with HealthTech Park Zurich-Schlieren innovation hub for healthcare startups.
- LuxinnovationminorPartnership with Luxinnovation, the Luxembourgish accelerator and innovation hub.
- BioLAGOminorDiagnostics network membership with BioLAGO, the cross-border healthcare network in the Lake Constance region.
- AddvantedgeminorPartnership with Addvantedge, a startup advisory for investment strategy and business modeling.
- KAPSLY PlatformminorPartnership with KAPSLY Platform, a service-for-equity startup network.
- Swiss BioLabminorPartnership with Swiss BioLab for biotech and MedTech laboratory services.
- EpmodexminorPartnership with Epmodex, a regulatory and engineering provider.
- ArcondisminorPartnership with Arcondis, a life science consultancy.
- Digital Health Center BülachminorPartnership with Digital Health Center Bülach, an innovation hub for healthcare startups.
- Evolution EuropeminorPartnership with Evolution Europe, an EU and national fundraising consultancy.
- Startup CampusminorPartnership with Startup Campus in Switzerland.
Scale indicators7 records
Recent moves7 records
Expansion highlights6 records
Effectum Medical competitors and assessment
Company assessmentDirect peers
- ProPharma Group: Pharma and MedTech regulatory and quality consulting firm offering ISO 13485, MDR, IVDR, and combination product consulting. Comparable to Effectum's regulatory strategy, Legal Manufacturer support, and pharma combination product work.
- Medidee Services: Swiss-based MedTech regulatory and quality management consultancy offering ISO 13485 implementation, CE marking, and clinical evaluation services. Closest like-for-like peer to Effectum Medical given shared Swiss HQ, MedTech QMS focus, and startup-to-SME client mix.
- Emergo by UL: UL's MedTech regulatory affairs and quality consulting arm offering ISO 13485, MDR/IVDR, and international registration services. Overlaps with Effectum on startup QMS, Legal Manufacturer-adjacent, and EU/US regulatory pathway services.
- Qserve Group: European MedTech regulatory affairs and quality management consultancy providing CE marking, ISO 13485, MDR/IVDR strategy, and post-market services. Comparable on regulatory service breadth and Europe-centric customer base.
- RQM+ (formerly RPS Consulting): MedTech-focused regulatory and quality consulting firm offering ISO 13485 QMS implementation, MDR/IVDR gap analysis, and Legal Manufacturer-adjacent services. Directly competes for the same startups and growth-stage MedTech customers.
Broad incumbents
- NAMSA: US-headquartered MedTech-focused CRO offering regulatory, quality, clinical, and laboratory testing services. Competes for MedTech regulatory and QMS engagements, though larger scale and more clinical/lab oriented.
- BSI Group: UK-based notified body and standards consultancy offering ISO 13485 certification, MDR/IVDR services, and adjacent QMS consulting. Larger, broader portfolio with overlapping capabilities to Effectum's compliance services.
- TÜV SÜD: Global notified body and TIC (testing, inspection, certification) provider offering ISO 13485, MDR/IVDR, and medical device QMS services. Broader scope than Effectum but competes for adjacent regulatory compliance engagements.
- DEKRA Certification: Global TIC and notified body offering ISO 13485, MDR/IVDR, and medical device certification plus adjacent QMS consulting. Larger incumbent with broader portfolio that overlaps Effectum's regulatory pathway services.
- Lloyd's Register Advena: European-focused MedTech regulatory consultancy (formerly separate Advena) part of Lloyd's Register, providing ISO 13485, MDR/IVDR consulting, and PRRC/person responsible services. Direct overlap on EU Legal Manufacturer-adjacent work.
Market position
Strengths5 records
Weaknesses4 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Effectum Medical social profiles
Digital presenceEffectum Medical compliance and trust
Trust signalCompliance1 record
Effectum Medical financial estimates
Financial estimateRevenue estimate
Valuation estimate
Effectum Medical leadership team
Management profileNumber of profiles
Profiles14 records
Effectum Medical subsidiaries and ownership
Company hierarchySubsidiaries1 record
Effectum Medical funding detail
Funding detailFunding overview
Funding rounds
Investors
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Effectum Medical M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Effectum Medical
What does Effectum Medical do?
Effectum Medical AG is a Swiss MedTech regulatory services firm that enables medical device innovators to achieve CE-marking under MDR/IVDR by acting as their Outsourced Legal Manufacturer and providing pre-built ISO 13485-compliant Plug & Play Quality Management Systems, on-demand senior QA/RA consulting (Rent an Expert), Regulatory Opinions for classification and approval pathway analysis, and AI/ML Expert compliance services for AI-driven medical devices. The company combines QM infrastructure with advisory capacity to accelerate EU market entry for startups, SMEs, and global pharmaceutical companies.
Is Effectum Medical a public or private company?
Effectum Medical is a private company. It is classified as founder individual operated bootstrapped and is currently operating.
When was Effectum Medical founded?
Effectum Medical was founded in 2017. It employs 11 to 50 people.
Where is Effectum Medical based?
Effectum Medical is headquartered in Olten, Switzerland, in the Europe region.
How does Effectum Medical make money?
Five revenue lines are on record. Legal Manufacturer Services are the primary driver. The others are plug & Play QMS Subscription, rent an Expert, regulatory Opinions and AI/ML Expert Services.
Who are Effectum Medical's main competitors?
Direct peers on record are ProPharma Group, Medidee Services, Emergo by UL, Qserve Group and RQM+ (formerly RPS Consulting). Broad incumbents are NAMSA, BSI Group, TÜV SÜD, DEKRA Certification and Lloyd's Register Advena.
Does Effectum Medical have an API?
No public API is recorded for Effectum Medical.
What industry is Effectum Medical in?
Effectum Medical's product category is MedTech Regulatory Services. Its primary akta.pro industry code is HLAGAKAD, Quality Management Systems (QMS) & GxP Documentation, with a secondary code of HLAGAKAJ, Manufacturing Quality Assurance & GMP Compliance (batch release, deviation/CAPA, tech transfer QA). Its NAICS code is 54169 and its SIC code is 8731.