Quality and regulatory affair
for Medical Devices and IVDs
Strategic, technical, and regulatory compliance services for the medical sector
Specialized consulting
for the medical device and IVD sector
Our priority at Altrion is to ensure your success.
To do this, we help you:
- achieve regulatory compliance;
- improve the effectiveness of your organization;
- improve performance;
- expand your business.
We are here to ensure that the process is well planned and executed.
Our team has experience in a wide variety of business processes, which is why
we assure you that you will achieve the best results every time.
The right choice for the best results
A team dedicated to your business
With over 10 years of experience in the medical device industry and the expertise gained from numerous projects developed for our clients, we can help your business approach industry regulations correctly from the outset, without wasting your valuable time.
Marking of medical devices and IVDs
With this service, we provide you with assistance and advice to enable your product to obtain the necessary certifications for marketing in the European Community and the United Kingdom.
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.
CANADA LICENCES (MDL & MDEL)
Achieve Market Access in Canada with Confidence.
From classification to licence maintenance, we ensure full compliance with Health Canada’s requirements.
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
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-REP 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.
Corporate security
With this service, we set up management systems for information security, worker safety, and environmental protection.
INFORMATION SECURITY
ISO 27001
WORKER
SAFETY AND HEALTH
ISO 45001
ENVIRONMENTAL MANAGEMENT SYSTEMS
ISO 14001
Business development
With this comprehensive consulting service, we help you find the right solution for your business, selecting and proposing suitable suppliers and partners for steady growth.
Business Development
Specialized assistance for business development
Free professional advice
Book a free 30-minute one-on-one consultation with one of our professionals.
Tell us what you need, and we will clarify any doubts you may have.
Contact form
