ALTRION

ALTRION Sagl

ALTRION is a regulatory consulting company specialized in supporting medical device manufacturers in accessing the European, Swiss and UK markets.

ALTRION is a regulatory affairs and market access partner specialized in supporting medical device, IVD and cosmetic manufacturers in entering and maintaining access to the European, Swiss and UK markets. ALTRION was founded from the experience of long-standing independent regulatory professionals active in the European market, who joined forces to create a structured group while preserving the practical knowledge, flexibility and client-oriented approach typical of senior consultants. The team brings more than 15 to 20 years of experience in medical device regulatory affairs, technical documentation, market access and post-market compliance. Through its group entities, ALTRION provides European Authorised Representative (EU REP), Swiss Authorised Representative (CH REP) and UK Responsible Person (UK RP) services for non-EU, non-Swiss and non-UK manufacturers. The company acts as the regulatory contact point with competent authorities, including EU authorities, Swissmedic and MHRA, and supports manufacturers in fulfilling their post-market, vigilance and registration obligations. ALTRION’s services include regulatory representation, technical documentation review, MDR/IVDR compliance support, UDI and EUDAMED assistance, Swissdamed support, MHRA device registration, PMS, PMCF, PSUR, vigilance support, FSCA and recall communication support, labelling and IFU review, importer and distributor coordination, and regulatory lifecycle maintenance. ALTRION typically works with international manufacturers, distributors and MedTech companies seeking a reliable, responsive and commercially practical regulatory partner in Europe, Switzerland and the United Kingdom. The company combines senior regulatory expertise with hands-on operational support, helping clients identify documentation gaps, prepare market access strategies and maintain compliance after market entry.

About

**Who they are**<br>ALTRION is a regulatory consulting firm specializing in supporting medical device manufacturers in accessing European, Swiss, and UK markets. They offer services including European Authorised Representative (EU REP), Swiss Authorised Representative (CH REP), and UK Responsible Person (UKRP).<br><br>**Expertise &amp; scope**<br>* Regulatory consulting for medical device manufacturers.<br>* European Authorised Representative (EU REP) services.<br>* Swiss Authorised Representative (CH REP) services.<br>* UK Responsible Person (UKRP) services for non-EU manufacturers.<br>* Support for MDR/IVDR, Swissmedic, and MHRA requirements.<br>* Assistance with technical documentation, registrations, UDI/EUDAMED/Swissdamed.<br>* Post-market surveillance, vigilance, PMS/PMCF/PSUR support.<br>* Maintenance of regulatory compliance throughout the device lifecycle.<br>* Support for CE marking and UKCA marking.<br>* Expertise in ISO 13485, ISO 14971, IEC 60601-1/60601-1-2, IEC 62304, IEC 62366, sterilization, biocompatibility, LVD/EMC, RED, MDSAP, FDA 510(k), and Health Canada licensing.<br><br>**Reputation / proof points**<br>* Founded and directed by Eng. Giacomo Cornara and Eng. Fabrizio Cavagnoli, who have extensive experience in the medical device sector.<br>* Giacomo Cornara is founder and director of MDQ Services Ltd, co-founder of Elite Med Group Sagl, and owner of MDQ di Giacomo Cornara SAS, further demonstrating their involvement in regulatory pathways and representative services.<br>* ALTRION has a London-based entity for its UKRP services.

Additional information

For non-UK manufacturers seeking to place medical devices or IVDs on the Great Britain market, appointing a UK Responsible Person (UKRP) is a mandatory requirement under the UK Medical Devices Regulations 2002. ALTRION, through its London-based entity, provides comprehensive UKRP representation. This service includes managing MHRA registration for all device classes, ensuring documentation monitoring, labeling compliance, vigilance coordination, and ongoing communication with the MHRA. They assist in structuring the representation process and submitting required information for device registration, ensuring compliance with UK regulatory frameworks.

Key Highlights

  • ALTRION provides UK Responsible Person (UKRP) services for medical devices and IVDs, supporting MHRA registration for all device classes.
  • The company offers European Authorised Representative (EU REP) and Swiss Authorised Representative (CH REP) services.
  • ALTRION assists manufacturers with a broad range of regulatory and quality management tasks, including technical documentation, vigilance, and post-market surveillance.
  • Expertise covers key medical device regulations including MDR/IVDR, Swissmedic, and MHRA requirements.

Certifications & Trust Signals

  • ALTRION is led by Eng. Giacomo Cornara and Eng. Fabrizio Cavagnoli, who have extensive experience in the medical device sector.
  • Giacomo Cornara's background includes founding MDQ Services Ltd and co-founding Elite Med Group Sagl, organizations involved in CE marking, UKCA marking, FDA, Health Canada regulatory pathways, and representative services.

Buyer Snapshot

Best for
  • Non-UK manufacturers needing UK Responsible Person services.
  • Medical device and IVD manufacturers seeking EU, Swiss, and UK market access.
  • Companies requiring support with technical documentation and regulatory compliance.
How engagement typically works
  • Partnership approach to ensure projects meet high standards.
  • Personalized advice tailored to specific client needs.
  • Comprehensive support throughout the device lifecycle.
Typical deliverables
  • UKRP appointment and MHRA registration.
  • Technical documentation and labeling verification.
  • Vigilance coordination and PMS reporting.
  • Ongoing liaison with MHRA.
  • Archiving of technical and regulatory documentation.
  • Annual compliance verification.
Good to know
  • Best when manufacturers lack a legal presence in the UK and require official representation.
HQ: Mendrisio, Switzerland
Languages: English-italian-french
Claim status: Claimed

Services & Capabilities

Find EU Authorized Rep (EC REP) | Compare & Get Quotes

Jurisdictions: EU
Countries: EU
Industries: MedicalDevice-IVD-SaMD
Portfolio: 1-5
Response SLA: 24 hours
Onboarding time: 5–20 days
Pricing model: per_market
Starting from: EUR 1,000
Included services: EU Authorised Representative mandate, regulatory contact point for EU competent authorities, verification of MDR/IVDR documentation availability, review of Declaration of Conformity and CE documentation, mandate agreement management, incident and vigilance communication support, FSCA and recall communication support, complaints and PMS event forwarding, EUDAMED actor registration support, label and IFU EU REP details verification, manufacturer regulatory liaison, maintenance of authorised representative records
Supports MDR: Yes
Supports IVDR: Yes
Device Classes Supported: Class I, Class IIb, Class Is/Im/Ir, Class IIa, IVD, Class III
Post Market Support: Yes
Labeling Review: Yes
EU Entity Country: Italy
Can Be Named On Label: Yes
Vigilance Contact Support: Yes
Fsca Recall Support: Yes

uk_rp

Jurisdictions: UK
Countries: UK
Industries: MedicalDevice-IVD-SaMD
Portfolio: 26-100
Response SLA: 24 hours
Onboarding time: 5–20 days
Starting from: GBP 1,000
Included services: UK Responsible Person mandate, regulatory contact point for MHRA, MHRA device registration support, verification of UKCA/CE documentation availability, review of Declaration of Conformity and certification documents, mandate agreement management, incident and vigilance communication support, FSCA and recall communication support, complaints and PMS event forwarding, manufacturer regulatory liaison, UK importer coordination, label and IFU UK RP details verification, maintenance of UK Responsible Person records
Supports GB: Yes
Supports NI: Yes
Device Classes Supported: Class I, Class IIa, Class IIb, Class III, IVD
MHRA Support: Yes
Can Be Named On Label: Yes
MHRA Portal Support: Yes
Vigilance Support: Yes

ch_rep

Jurisdictions: CH, US, Global
Countries: Word
Industries: MedicalDevice-IVD-SaMD
Portfolio: 100+
Response SLA: 24 hours
Onboarding time: 5–20 days
Pricing model: per_market
Starting from: CHF 1,000
Included services: Swiss Authorised Representative mandate, regulatory contact point for Swissmedic, verification of Swiss regulatory requirements, review of Declaration of Conformity and CE documentation, mandate agreement management, incident and vigilance communication support, FSCA and recall communication support, complaints and PMS event forwarding, Swissmedic communication support, Swissdamed registration support, label and IFU CH REP details verification, importer and distributor coordination, maintenance of authorised representative records
Device Classes Supported: Class I, Class IIa, Class IIb, IVD, Class III
Swiss Local Contact: Yes
Labeling Support: Yes
Swiss Entity Canton Or Region: Ticino
Can Be Named On Label: Yes
Vigilance Contact Support: Yes

eudamed_reg_support

Jurisdictions: EU
Countries: EU
Industries: MedicalDevice-IVD-SaMD
Portfolio: 100+
Onboarding time: 5–20 days
Pricing model: Per project
Starting from: EUR 500
Included services: EUDAMED actor registration, SRN application, Actor module assistance, manufacturer account setup guidance, company data validation, actor data validation, Local Actor Administrator configuration support, registration information review before submission, competent authority validation support, registration issue troubleshooting, post-registration support, EUDAMED account maintenance guidance
Supports Actor Registration: Yes
Supports UDI: Yes
Supports Data Load: Yes
Modules Supported: Actor/SRN, UDI/Devices, Vigilance, Certificates
Supports Training Enablement: No
Data Load Support Level: Done-for-you
Turnaround SLA: 1-3 days

eudamed_onboarding_support

Jurisdictions: EU
Countries: EU
Industries: MedicalDevice-IVD-SaMD
Portfolio: 100+
Response SLA: 24 hours
Onboarding time: 5–20 days
Starting from: EUR 500
Included services: EUDAMED onboarding support, Actor module support, UDI/Device module support, device data preparation, Basic UDI-DI data review, UDI-DI data review, manufacturer information verification, device information verification, XML data preparation support, manual data entry support, mandatory device data registration, regulatory information review, market information review, submission error troubleshooting, validation message support, data consistency checks, EUDAMED maintenance guidance
Modules Supported: Actor/SRN, UDI/Devices, Certificates, Market Surveillance
Submission Approach: Bulk Submissions, Portal
Portfolio Fit: 100+
Onboarding Speed: 1-2 weeks
Managed Service Available: Yes

cosmetics_rp

Jurisdictions: EU, UK
Countries: EU-UK
Industries: Cosmetics
Portfolio: 26-100
Response SLA: 24 hours
Onboarding time: 5–20 days
Pricing model: Custom pricing
Included services: EU cosmetics compliance support, UK cosmetics compliance support, Responsible Person support, Cosmetic Product Safety Report review, Product Information File review, Product Information File maintenance support, CPNP notification support, SCPN notification support, label review, claims review, ingredient compliance check, formulation compliance check, allergen verification, warning verification, GMP documentation review, importer compliance support, distributor compliance support, post-market surveillance support, cosmetovigilance support, regulatory contact handling
Supports CPNP: Yes
Supports PIF: Yes
Label Review Included: Yes
Supports CPSR: Yes
Supports Regulatory Consulting: Yes
Supports Formula Compliance Checks: No
Supports Testing Coordination Management: Yes
Supports Claims Substantiation: Yes
Supports Ukcosmetics Rp: Yes
Can Provide Local Address On Label: Yes
Turnaround SLA: 1-3 days

Additional eu_ar Details

Device Classes Supported
All device classes (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
Italy (implied by ALTRION Srl address)
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Requires appointment of a European Authorized Representative (EU-REP) for non-EU manufacturers. Involves EUDAMED registration, documentation review, vigilance coordination, and regulatory communication.
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