AIRMEDICE

AIRMEDICE is a consultancy that specialises in the 𝐪𝐮𝐚𝐥𝐢𝐭𝐲 𝐚𝐧𝐝 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐢𝐨𝐧 𝐨𝐟 𝐦𝐞𝐝𝐢𝐜𝐚𝐥 𝐝𝐞𝐯𝐢𝐜𝐞𝐬. 📌 𝐖𝐡𝐚𝐭 𝐰𝐞 𝐨𝐟𝐟𝐞𝐫: • Implementation or modification of your quality system (ISO 13485), • Creating or updating your CE marking technical files in compliance with the applicable regulations and standards (Regulation (EU) 2017/745, safety of electro-medical devices: IEC 60601-1, software: IEC62304, usability: IEC 62366-1, risk management: ISO 14971, etc.), • Creating or modification of your Design File, • Regulatory strategy and support, • Support even from the design phase, • Structuring your R&D projects with a vision of compliance, • Creating or updating your design files, • Preparing for export. 🚀 𝐓𝐡𝐞 𝐠𝐨𝐚𝐥 𝐢𝐬 𝐭𝐨 𝐟𝐫𝐞𝐞 𝐲𝐨𝐮 𝐟𝐫𝐨𝐦 𝐫𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐜𝐨𝐦𝐩𝐥𝐞𝐱𝐢𝐭𝐲 𝐬𝐨 𝐭𝐡𝐚𝐭 𝐲𝐨𝐮 𝐜𝐚𝐧 𝐜𝐨𝐧𝐜𝐞𝐧𝐭𝐫𝐚𝐭𝐞 𝐨𝐧 𝐢𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧. You save time, anticipate the authorities' expectations and accelerate your access to the market. 👉 How we could help you? Contact us here or at contact@airmedice.com