Official legal representation ensuring direct communication with international competent health authorities
Based at our registered office in Skรฆvinge, Denmark (CVR: 45000524, SRN: DK-AR-000043850). We fulfill all duties under Article 11 of EU MDR 2017/745 and IVDR 2017/746, maintaining technical documentation, notifying competent authorities, and executing vigilance.
Mandatory for non-UK manufacturers selling into Great Britain. We register your medical devices and IVDs with the MHRA, manage technical files, and handle local UK post-market inquiries.
Official representation in compliance with Swiss MedDO and IvDO ordinances. Direct regulatory interface with Swissmedic and management of SWISSDAMED notification protocols.
Legal US Agent presence based in Illinois. Managing annual FDA establishment registration, official device listings, inspection notifications, and 510(k) communication.
Acting as your Australian In-Country Sponsor to list and maintain your medical devices in the Australian Register of Therapeutic Goods (ARTG) with ongoing TGA liaison.
Designated In-Country Legal Representative for overseas manufacturers submitting to China’s National Medical Products Administration (NMPA).
Multi-continent market clearance, dossier preparation, and national health licensing
Specialized technical files compilation, database management, and clinical compliance
Comprehensive gap analysis, Technical Documentation preparation according to Annex II & III, General Safety and Performance Requirements (GSPR) checklist verification, and Notified Body audit readiness.
Contract Research Organization (CRO) solutions, Clinical Evaluation Plans & Reports (CEP/CER) compliant with MEDDEV 2.7/1 Rev 4 & MDR, Performance Evaluation Reports (PER) for IVD, and PMCF design.
Implementation of ISO 13485:2016 Quality Management Systems, internal pre-audits, Manufacturing License applications, and global Import License coordination.
Actor registration and Single Registration Number (SRN) procurement on EUDAMED and SWISSDAMED, UDI assignment, and Free Sales Certificates (FSC / CFS) issuance from competent authorities.
Article 13 MDR compliance, Spanish customs entry, and consumer protective regulations
Fulfilling the legal mandates of Article 13 MDR/IVDR. We verify CE certification, device labeling compliance, EU declaration of conformity, and maintain storage conditions for imported batches.
Dedicated customs and regulatory support for medical device importation into Spain, handling AEMPS (Agencia Espaรฑola de Medicamentos y Productos Sanitarios) requirements and regional distributors.
EU Cosmetics Responsible Person (Regulation EC 1223/2009), CPNP notifications, Personal Protective Equipment (PPE Regulation 2016/425) legal representation, and General Product Safety Regulation (GPSR) compliance.
Executive educational sessions for Quality Managers, Regulatory Affairs (RA) personnel, and executives
Our Danish and international regulatory consultants organize customized in-house corporate workshops and interactive webinars covering:
Contact our headquarters in Skรฆvinge, Denmark or our international coordination offices
Connect directly with our regulatory specialists for European Authorized Representation (EU REP), Swiss representation, US FDA Agent support, or worldwide device registrations.