Quality and regulatory affairs for Medical Devices and IVDs

Strategic, technical, and regulatory compliance services for the medical sector

Global Market Access

From European CE marking to North American certifications, Altrion provides end-to-end regulatory support across the world's most demanding medical device markets.

CE MARK (EU)

Access the European medical device market under MDR/IVDR compliance. ALTRION supports full conformity assessment, Technical File review, and post-market surveillance across the EU.

UKCA MARK (UK)

Ensure compliance with UK MDR 2002 and MHRA registration. Our London office acts as your UK Responsible Person (UKRP) to maintain post-Brexit access to the UK market.

FDA 510(k) SUBMISSION (USA)

Your gateway to the U.S. medical device market. Navigate the FDA clearance process with strategic guidance, complete documentation support, and U.S. Agent representation.

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MFDS REGISTRATION (KOREA)

Enter the South Korean medical device market through MFDS approval and MDMS submission. ALTRION manages registration, KGMP compliance, and KLH appointment for all device classes.

Quality Management Service

With this service, we provide support in the drafting and implementation of quality management systems, to achieve policies and objectives that define the quality of a medical device.

Quality Management

Systems for documenting processes, procedures, and responsibilities for achieving quality policies and objectives.

PRRC

Person responsible for compliance with regulations.

Regulatory Representation Services

Global representation for regulatory compliance and market entry. ALTRION provides trusted representation for manufacturers worldwide who need a local regulatory presence to place medical devices on the market in the European Union, United Kingdom, Switzerland, United States, and Canada. Our offices and partners ensure regulatory accountability, transparent communication with authorities, and continuous post-market vigilance.

EU Authorized Representative

Ensure MDR/IVDR compliance across Europe. ALTRION acts as your EU Authorized Representative, managing EUDAMED registration, vigilance, and liaison with Competent Authorities.

UKRP – UK Responsible Person

Your legal representative for the UK market. Our London office ensures MHRA registration, post-market surveillance, and compliance under UK MDR 2002.

CH-REP Swiss Authorized Representative

Your Swiss regulatory representative under MedDO. ALTRION in Switzerland provides CH-REP services and manages product registration in Swissdamed.

U.S. Agent & Initial Importer (FDA)

Your U.S. regulatory point of contact. ALTRION represents foreign manufacturers before the FDA, acting as official agent and, if required, Initial Importer for medical devices.

KLH – Korea License Holder

Your independent legal representative before MFDS. ALTRION manages product registration, KGMP certification, and multi-distributor coordination for medical devices in South Korea.

Corporate Security

With this service, we set up management systems for information security, worker safety, and environmental protection.

Information Security

ISO 27001 — Information security management system for protecting organisational data, processes, and assets.

Worker Safety and Health

ISO 45001 — Occupational health and safety management system to reduce workplace risks and protect your workforce.

Environmental Management Systems

ISO 14001 — Environmental management framework to minimise environmental impact and demonstrate sustainability commitment.

Business Development

We help you find the right solution for your business, selecting and proposing suitable suppliers and partners for steady growth.

Medical device market access — worldwide.

All the services necessary for the development of companies in the medical sector

With decades of experience and an extensive network of manufacturers, suppliers, and laboratories, we provide tailored consulting services for business growth, cost efficiency, and product innovation.

Identifying and introducing key partners for sales, distribution, supply chain, product development, and specialised services
Access to a curated network of private label companies and accredited testing and calibration laboratories
Research, qualification, and selection of potential business partners
Product development guidance, improvement roadmaps, and business model definition to grow your market presence

These are just some of the opportunities we offer. Contact us for a tailored service.

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