G.M.E. products are designed, manufactured, and tested to meet the regulatory and quality requirements applicable to emergency medical devices in the European Union and the partner jurisdictions our distributors serve. This page summarises our compliance posture. Specific certificate numbers, notified-body references, and per-product documentation are available on request to qualified buyers.
All G.M.E. medical products fall within the scope of Regulation (EU) 2017/745 (Medical Device Regulation). Products are classified, declared, and CE-marked in accordance with the regulation. Manufacturer responsibilities — including post-market surveillance, vigilance, and unique device identification (UDI) — are operated within Active Resilience Solutions GmbH’s quality system.
Every component that touches the casualty — fabric, adhesive, plastic, gel, metal — is specified from suppliers that document compliance with applicable medical-device material standards. We maintain material traceability through the supply chain from raw stock to packaged unit.
Products undergo functional testing during production and additional evaluation in real operational conditions through the Field-Tested programme. Findings flow back into design revision — the development cycle is Development → Use → Improvement, not Development → Catalogue.
G.M.E. products are not subject to the International Traffic in Arms Regulations. They are dual-use medical equipment intended for civilian, public-authority, EMS, and military medical use, with no ITAR-controlled content.
Procurement officers, distributors, and public-authority buyers can request the current declaration of conformity, technical file summary, and lot-level test data for any G.M.E. product. Email info@activeresiliencesolutions.de with the product name and intended jurisdiction.